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Spinal Cord Associative Plasticity Study (SCAP)

Primary Purpose

Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive pairing of cortical and spinal stimulation
Intraoperative pairing of cortical and spinal stimulation
Non-invasive repeated pairing of cortical and spinal stimulation (SCAP)
Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)
Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cervical Spinal Cord Injury focused on measuring spinal cord injury, paired brain and spinal cord stimulation, convergent stimulation, spinal cord associative plasticity, transcutaneous spinal cord stimulation, intraoperative monitoring, upper-limb muscle activation, motor cortex, cervical spinal cord

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

NON-INVASIVE

Inclusion Criteria:

(All participants)

  • Age between 18-80 years.
  • Must have stable prescription medication for 30 days prior to screening
  • Must be able to: abstain from alcohol, smoking and caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent.

(Able-bodied participants)

  • No known central or peripheral neurological disease or injury.

(SCI participants - including patients scheduled for intraoperative procedures)

  • Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.

Exclusion criteria:

(All participants)

  • Personal or extensive family history of seizures;
  • Ventilator dependence or patent tracheostomy site;
  • Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
  • History of stroke, brain tumor, brain abscess, or multiple sclerosis;
  • History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
  • History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;
  • Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV;
  • Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
  • History of significant hearing problems;
  • History of bipolar disorder;
  • History of suicide attempt;
  • Active psychosis;
  • Recent history (>1 year) of chemical substance dependency or significant psychosocial disturbance;
  • Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
  • Open skin lesions over the face, neck, shoulders, or arms;
  • Pregnancy; and
  • Unsuitable for study participation as determined by study physician.

INTRA-OPERATIVE

Inclusion Criteria:

  • Clinical indication for cervical spine surgery.

Exclusion criteria:

(For experiments involving cortical stimulation)

  • Epilepsy;
  • A history of skull surgery with metal implants;
  • Cochlear implants;
  • Patients with aneurysm stents in neck or brain blood vessels;
  • Evidence of skull shrapnel; (For experiments involving spinal cord stimulation)
  • Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)

Sites / Locations

  • Bronx Veterans Medical Research Foundation, IncRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1. Uninjured participants - Immediate and lasting effects of non-invasive paired stimulation

2. Intraoperative participants - Immediate effects of paired stimulation

3. Intraoperative participants - Lasting effects of SCAP

4. Chronic cervical SCI participants - Lasting effects of non-invasive SCAP

5. Intraoperative participants - Lasting effects of SCAP at or below myelopathic region

Arm Description

Participants will take part in the following to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).

Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Intraoperative pairing of cortical and spinal stimulation.

Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP).

Participants with chronic cervical SCI will take part in the following, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).

Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region.

Outcomes

Primary Outcome Measures

Size of hand muscle response to brain stimulation during combined brain and spinal stimulation
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the muscle response for brain only stimulation. This applies to Arms 1-2.
Size of hand muscle response to brain stimulation after SCAP
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol. This applies to Arms 3-5.

Secondary Outcome Measures

Size of hand muscle response to spinal cord stimulation
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol.
Duration of effect of SCAP on subsequent responses to brain or spinal cord stimulation
Time taken for the size of hand muscle response to fall to 50% of its maximal post-SCAP level.
Pinch force
Pinch opposition strength between the tips of the thumb and third finger (a task highly dependent on cortical transmission to C8-T1 spinal circuitry will be measured using a handheld dynamometer. Force and root mean square (RMS) of electromyographic activity will be recorded. Maximal pinch dynamometry will be compared to baseline measurement.
Amplitudes of H-reflex ratio
H-reflex amplitudes (Hmax/Mmax), a biomarker for spasticity triggered with 1.0 ms pulses over the median nerve at the elbow.
Threshold for triggering muscle response from brain stimulation
The threshold for transcutaneous cortical electrical stimulation will be measured by increasing the voltage from 50V in 50V steps, until a MEP is detected.
Threshold for triggering muscle response from spinal cord stimulation
The threshold for spinal cord stimulation will be measured by increasing the stimulation amplitude from 1mA in 1mA steps, until an evoked potential is observable in the target muscle, or our safety limit is reached. In cases where clear evoked responses cannot be generated within stimulation amplitude safety limits, 3 pulse stimuli will be used, or investigator will modify target muscle for the remainder of the experiment. Study will target APB, but more responsive muscles may be substituted.
Size of hand muscle response to spinal cord stimulation (lasting)
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol.
Pinch force (lasting)
Pinch opposition strength between the tips of the thumb and third finger (a task highly dependent on cortical transmission to C8-T1 spinal circuitry will be measured using a handheld dynamometer. Force and root mean square (RMS) of electromyographic activity will be recorded. Maximal pinch dynamometry will be compared to baseline measurement.
Amplitudes of H-reflex ratio (lasting)
H-reflex amplitudes (Hmax/Mmax), a biomarker for spasticity triggered with 1.0 ms pulses over the median nerve at the elbow.
Threshold for triggering muscle response from brain stimulation (lasting)
The threshold for spinal cord stimulation will be measured by increasing the stimulation amplitude from 1mA in 1mA steps, until an evoked potential is observable in the target muscle, or our safety limit is reached. In cases where clear evoked responses cannot be generated within stimulation amplitude safety limits, 3 pulse stimuli will be used, or investigator will modify target muscle for the remainder of the experiment. Study will target APB, but more responsive muscles may be substituted.

Full Information

First Posted
November 23, 2021
Last Updated
April 24, 2023
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Weill Medical College of Cornell University, Bronx Veterans Medical Research Foundation, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05163639
Brief Title
Spinal Cord Associative Plasticity Study
Acronym
SCAP
Official Title
Spinal Cord Associative Plasticity Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Weill Medical College of Cornell University, Bronx Veterans Medical Research Foundation, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spinal cord associative plasticity (SCAP) is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand function in spinal cord injury. The proposed study will advance understanding of SCAP, which is critical to its effective translation to human therapy. The purpose of the study is to: Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation. Improve our understanding of the spinal cord and how it produces movement. Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function. Aim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity (SCAP). Aim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing. In rats, SCAP augments muscle activation for hours after just 5 minutes of paired stimuli. Whereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord, Aim 3 assesses whether paired stimulation can be effective across injured cord segments. Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI, either traumatic or pre-operative patients with myelopathy in non-invasive experiments, or targeting myelopathic segments in intraoperative segments.
Detailed Description
For people with cervical spinal cord injury (SCI), regaining hand function is their highest priority. Currently there are no effective treatments for people living with paralysis or profound weakness after SCI. The goal of this project is to translate a promising therapy for improving arm and hand function after partial spinal cord injury to humans. The approach promotes repair of residual brain to spinal cord connections using combined motor cortex and spinal cord stimulation. The direct brain to spinal cord connection is critical for skilled hand movement in health, and for the loss of movement after injury. After spinal cord injury, many nerve connections for movement are preserved. These connections can be strengthened by electrical stimulation. The investigator has previously demonstrated that pairing brain and spinal cord stimulation strengthens spinal connections in rats. But it is unknown whether this is also applicable in humans. This study is designed to test this in people undergoing spine surgery for pain or decreased movement as well as non-invasively in people with traumatic spinal cord injury. There are three main goals of this project. First, the investigator will stimulate brain and spinal cord (intra-operatively and non-invasively) to try to study the influence of the timing of pairing brain and spinal cord stimulation. Second, the investigator will study how repeating the optimal timing (spinal cord associative plasticity; SCAP) will influence muscle responses over a longer period of time when relatively uninjured parts of the spinal cord are targeted. Finally, the investigator will study how the influence of this protocol changes when injured parts of the cord are targeted. Stimulation of brain and spinal cord intra-operatively will be performed with the same devices that maintain safety during the surgery, while non-invasive stimulation will be performed with non-significant risk devices. Participants: Uninjured volunteers, individuals with chronic (> 1 year) cervical SCI, and individuals with cervical myelopathy or radiculopathy requiring clinically indicated decompressive surgery will be recruited. SCI and myelopathy participants will have partially retained motor function in the hand, scoring 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand. Participants will also require detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation and/or first dorsal interosseous muscle (FDI) to ulnar nerve stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy
Keywords
spinal cord injury, paired brain and spinal cord stimulation, convergent stimulation, spinal cord associative plasticity, transcutaneous spinal cord stimulation, intraoperative monitoring, upper-limb muscle activation, motor cortex, cervical spinal cord

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants with chronic SCI, participants with spondylotic radiculopathy or myelopathy scheduled to undergo elective cervical decompression surgery, and volunteers without neural injury will be prospectively enrolled in this interventional experimental study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Uninjured participants - Immediate and lasting effects of non-invasive paired stimulation
Arm Type
Experimental
Arm Description
Participants will take part in the following to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Arm Title
2. Intraoperative participants - Immediate effects of paired stimulation
Arm Type
Experimental
Arm Description
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Intraoperative pairing of cortical and spinal stimulation.
Arm Title
3. Intraoperative participants - Lasting effects of SCAP
Arm Type
Experimental
Arm Description
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP).
Arm Title
4. Chronic cervical SCI participants - Lasting effects of non-invasive SCAP
Arm Type
Experimental
Arm Description
Participants with chronic cervical SCI will take part in the following, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Arm Title
5. Intraoperative participants - Lasting effects of SCAP at or below myelopathic region
Arm Type
Experimental
Arm Description
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region.
Intervention Type
Procedure
Intervention Name(s)
Non-invasive pairing of cortical and spinal stimulation
Intervention Description
Transcranial magnetic stimulation (TMS) threshold, Transcutaneous spinal cord stimulation (TSCS) threshold, and peripheral and central motor conduction times will be determined. In the active intervention, two TMS pulse intensities will be tested: 90% and 120% of motor threshold. Two conditioning TSCS pulse intensities will be tested: 50% and 90% of response threshold. Single TSCS pulses will be delivered timed to arrive in the cervical spinal cord at a range of intervals from 30ms before to 30ms after the TMS pulse. The control conditions will include TMS only TSCS only and non-convergent pairing latency pairing stimulation.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative pairing of cortical and spinal stimulation
Intervention Description
The surgeon will position spinal cord electrodes on the epidural surface one level rostral (typically C4/C5) to the site of myelopathy. Spinal and cortical thresholds will be determined. Investigator will then test the immediate effects of paired stimulation by stimulating the cortex at 120% of threshold and the spinal cord at 90% of threshold at various latencies relative to the time of synchronous convergence. The control intervention will include cortical only (120%) spinal only (90%) and non-convergent latency pairing stimulation.
Intervention Type
Procedure
Intervention Name(s)
Non-invasive repeated pairing of cortical and spinal stimulation (SCAP)
Intervention Description
Thresholds will be determined as above. Immediately prior to repetitive pairing, a set of 12 TMS pulses will be delivered at 120% threshold to measure the baseline cortical MEP. Likewise, a set of 12 TSCS pulses will be delivered at 120% of threshold to establish the baseline spinal MEP. For each session, baseline maximal pinch dynamometry will be determined. Immediately after the SCAP protocol is completed, response to TMS, TSCS, and maximal pinch dynamometry will be measured again every 10 minutes over the subsequent hour. The control conditions will include TMS only TSCS only and non-convergent pairing latency pairing stimulation.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)
Intervention Description
Intraoperative: Spinal and cortical thresholds will be determined. Immediately prior to repetitive pairing, a set of 12 baseline cortical pulses and 12 baseline spinal pulses will be delivered at 120% threshold. SCAP protocol will be applied, both of which have been successful at inducing lasting effects in the rat. After pairing, cortical stimulation at 120% of threshold and spinal cord stimulation at 120% threshold will be repeated every 10 minutes for the duration of surgery. In a subset of patients repeated pairing will be conducted with a latency that investigator does not expect will induce SCAP, or with electrodes placed over the ventral epidural surface. The control intervention will include repeated pairing at a non-convergent latency, as well as pairing of cortical stimulation with ventral epidural stimulation.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region
Intervention Description
As per the intervention 'Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)' targeted at or below myelopathic region.
Primary Outcome Measure Information:
Title
Size of hand muscle response to brain stimulation during combined brain and spinal stimulation
Description
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the muscle response for brain only stimulation. This applies to Arms 1-2.
Time Frame
Immediate
Title
Size of hand muscle response to brain stimulation after SCAP
Description
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol. This applies to Arms 3-5.
Time Frame
Immediately after SCAP
Secondary Outcome Measure Information:
Title
Size of hand muscle response to spinal cord stimulation
Description
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol.
Time Frame
Immediately after SCAP
Title
Duration of effect of SCAP on subsequent responses to brain or spinal cord stimulation
Description
Time taken for the size of hand muscle response to fall to 50% of its maximal post-SCAP level.
Time Frame
1 hour after SCAP
Title
Pinch force
Description
Pinch opposition strength between the tips of the thumb and third finger (a task highly dependent on cortical transmission to C8-T1 spinal circuitry will be measured using a handheld dynamometer. Force and root mean square (RMS) of electromyographic activity will be recorded. Maximal pinch dynamometry will be compared to baseline measurement.
Time Frame
Immediately after SCAP
Title
Amplitudes of H-reflex ratio
Description
H-reflex amplitudes (Hmax/Mmax), a biomarker for spasticity triggered with 1.0 ms pulses over the median nerve at the elbow.
Time Frame
Immediately after SCAP
Title
Threshold for triggering muscle response from brain stimulation
Description
The threshold for transcutaneous cortical electrical stimulation will be measured by increasing the voltage from 50V in 50V steps, until a MEP is detected.
Time Frame
Immediately after SCAP
Title
Threshold for triggering muscle response from spinal cord stimulation
Description
The threshold for spinal cord stimulation will be measured by increasing the stimulation amplitude from 1mA in 1mA steps, until an evoked potential is observable in the target muscle, or our safety limit is reached. In cases where clear evoked responses cannot be generated within stimulation amplitude safety limits, 3 pulse stimuli will be used, or investigator will modify target muscle for the remainder of the experiment. Study will target APB, but more responsive muscles may be substituted.
Time Frame
Immediately after SCAP
Title
Size of hand muscle response to spinal cord stimulation (lasting)
Description
Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol.
Time Frame
30 minutes after SCAP
Title
Pinch force (lasting)
Description
Pinch opposition strength between the tips of the thumb and third finger (a task highly dependent on cortical transmission to C8-T1 spinal circuitry will be measured using a handheld dynamometer. Force and root mean square (RMS) of electromyographic activity will be recorded. Maximal pinch dynamometry will be compared to baseline measurement.
Time Frame
30 minutes after SCAP
Title
Amplitudes of H-reflex ratio (lasting)
Description
H-reflex amplitudes (Hmax/Mmax), a biomarker for spasticity triggered with 1.0 ms pulses over the median nerve at the elbow.
Time Frame
30 minutes after SCAP
Title
Threshold for triggering muscle response from brain stimulation (lasting)
Description
The threshold for spinal cord stimulation will be measured by increasing the stimulation amplitude from 1mA in 1mA steps, until an evoked potential is observable in the target muscle, or our safety limit is reached. In cases where clear evoked responses cannot be generated within stimulation amplitude safety limits, 3 pulse stimuli will be used, or investigator will modify target muscle for the remainder of the experiment. Study will target APB, but more responsive muscles may be substituted.
Time Frame
30 minutes after SCAP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
NON-INVASIVE Inclusion Criteria: (All participants) Age between 18-80 years. Must have stable prescription medication for 30 days prior to screening Must be able to: abstain from alcohol, smoking and caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent. (Able-bodied participants) No known central or peripheral neurological disease or injury. (SCI participants - including patients scheduled for intraoperative procedures) Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand. Exclusion criteria: (All participants) Personal or extensive family history of seizures; Ventilator dependence or patent tracheostomy site; Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion; History of stroke, brain tumor, brain abscess, or multiple sclerosis; History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging); History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation; Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV; Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures); History of significant hearing problems; History of bipolar disorder; History of suicide attempt; Active psychosis; Recent history (>1 year) of chemical substance dependency or significant psychosocial disturbance; Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours; Open skin lesions over the face, neck, shoulders, or arms; Pregnancy; and Unsuitable for study participation as determined by study physician. INTRA-OPERATIVE Inclusion Criteria: Clinical indication for cervical spine surgery. Exclusion criteria: (For experiments involving cortical stimulation) Epilepsy; A history of skull surgery with metal implants; Cochlear implants; Patients with aneurysm stents in neck or brain blood vessels; Evidence of skull shrapnel; (For experiments involving spinal cord stimulation) Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason B Carmel, M.D., Ph.D.
Phone
917-301-1882
Email
jbc28@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Y Harel, M.D., Ph.D.
Phone
212-241-7317
Email
noam.harel@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason B Carmel, M.D., Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx Veterans Medical Research Foundation, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noam Y Harel, M.D., Ph.D.
Phone
718-584-9000
Ext
1742
Email
Noam.harel@va.gov
First Name & Middle Initial & Last Name & Degree
Noam Y Harel, M.D., Ph.D.
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason B Carmel, MD, PhD
Phone
212-305-6616
Email
jbc28@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Jason B Carmel, M.D.
First Name & Middle Initial & Last Name & Degree
James R McIntosh, Ph.D.
First Name & Middle Initial & Last Name & Degree
Chris E Mandigo, M.D.
First Name & Middle Initial & Last Name & Degree
Ronald A Lehman, M.D.
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael S Virk, M.D., Ph.D.
Phone
503-494-4723
Email
miv2010@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Michael S Virk, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Daniel Riew, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified, individual-level data will be deposited to appropriate public repositories, such as Open Data Commons for Spinal Cord Injury (https://scicrunch.org/odc-sci), Figshare, or others. This will allow more powerful meta-analysis of disparate smaller studies, a need which is even more urgent in neurorehabilitation than in other fields that are more amenable to large drug studies.
IPD Sharing Time Frame
Within 6 months of manuscript preparation.
IPD Sharing Access Criteria
Individually identifiable data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions described in the authorization and consent. A Data Use Agreement (DUA) will indicate adherence to any applicable Informed Consent provisions, and prohibits the recipient from identifying or re-identifying any individual whose data are included in the dataset.

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Spinal Cord Associative Plasticity Study

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