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The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

Primary Purpose

Stroke, Cerebrovascular Accident (CVA), Hemiparesis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sham Doublestim
anodal Doublestim
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, CVA, Spasticity, hemiparesis, rehabilitation, trans-spinal direct current stimulation (tsDCS), non-invasive stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
  2. Cognitive function sufficient to understand the experiments and follow instructions
  3. A Modified Ashworth Scale score between 1-3 points for wrist flexor and extensor muscles
  4. A minimum of 15 degrees wrist passive range of motion (ROM) for wrist flexion and extension from wrist neutral position

Exclusion Criteria:

  1. Focal brainstem or thalamic infarcts
  2. Prior surgical treatments for spasticity of the upper limb
  3. Ongoing use of central nervous system (CNS)-active medications
  4. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
  5. Botox or phenol alcohol treatment within 12 weeks of enrollment
  6. Pregnancy in women, as determined by self-report
  7. History of spinal cord injury or weakness
  8. Chronic pain
  9. Peripheral neuropathy including insulin dependent diabetes as determined by case history

  10. Presence of additional potential tsDCS risk factors:

    • Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.)
    • Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
    • Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
    • Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months

Sites / Locations

  • Feinstein Institute for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham Doublestim

Anodal Doublestim

Arm Description

Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.

Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.

Outcomes

Primary Outcome Measures

Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)

Secondary Outcome Measures

Mean Modified Tardieu Scale (MTS) Score
The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim).

Full Information

First Posted
March 6, 2017
Last Updated
March 8, 2021
Sponsor
Northwell Health
Collaborators
PathMaker Neurosystems Inc., Dr. Zaghloul Ahmed
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1. Study Identification

Unique Protocol Identification Number
NCT03080454
Brief Title
The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
Official Title
The Effect of Treatment With the PathMaker Myoregulator Neuromodulation System Incorporating Trans-spinal Direct Current Stimulation (tsDCS) in Patients With Severe Hand Spasticity After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
PathMaker Neurosystems Inc., Dr. Zaghloul Ahmed

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker anodal DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pDCS-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident (CVA), Hemiparesis, Spasticity as Sequela of Stroke, Muscle Spasticity, Upper Extremity Paralysis
Keywords
stroke, CVA, Spasticity, hemiparesis, rehabilitation, trans-spinal direct current stimulation (tsDCS), non-invasive stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
All participants received both stimulation conditions (sham Doublestim and anodal Doublestim), separated by a 1-week washout period.
Masking
Participant
Masking Description
The sham stimulation condition preceded the anodal stimulation condition for all participants, and subjects were told they would receive both conditions, but were blinded to order of assignment.
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Doublestim
Arm Type
Placebo Comparator
Arm Description
Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
Arm Title
Anodal Doublestim
Arm Type
Active Comparator
Arm Description
Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.
Intervention Type
Device
Intervention Name(s)
sham Doublestim
Other Intervention Name(s)
sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)
Intervention Description
PathMaker MyoRegulator device
Intervention Type
Device
Intervention Name(s)
anodal Doublestim
Other Intervention Name(s)
anodal trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)
Intervention Description
PathMaker MyoRegulator device
Primary Outcome Measure Information:
Title
Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
Description
Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)
Time Frame
baseline, final session at day 5, 1 week FU
Secondary Outcome Measure Information:
Title
Mean Modified Tardieu Scale (MTS) Score
Description
The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim).
Time Frame
baseline, final session at day 5, 1 week FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior Cognitive function sufficient to understand the experiments and follow instructions A Modified Ashworth Scale score between 1-3 points for wrist flexor and extensor muscles A minimum of 15 degrees wrist passive range of motion (ROM) for wrist flexion and extension from wrist neutral position Exclusion Criteria: Focal brainstem or thalamic infarcts Prior surgical treatments for spasticity of the upper limb Ongoing use of central nervous system (CNS)-active medications Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications Botox or phenol alcohol treatment within 12 weeks of enrollment Pregnancy in women, as determined by self-report History of spinal cord injury or weakness Chronic pain Peripheral neuropathy including insulin dependent diabetes as determined by case history Presence of additional potential tsDCS risk factors: Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.) Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation) Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
Facility Information:
Facility Name
Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24478352
Citation
Ahmed Z. Trans-spinal direct current stimulation alters muscle tone in mice with and without spinal cord injury with spasticity. J Neurosci. 2014 Jan 29;34(5):1701-9. doi: 10.1523/JNEUROSCI.4445-13.2014.
Results Reference
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PubMed Identifier
25263206
Citation
Ahmed Z. Trans-spinal direct current stimulation modifies spinal cord excitability through synaptic and axonal mechanisms. Physiol Rep. 2014 Sep 28;2(9):e12157. doi: 10.14814/phy2.12157. Print 2014 Sep 1.
Results Reference
background
PubMed Identifier
27932680
Citation
Samaddar S, Vazquez K, Ponkia D, Toruno P, Sahbani K, Begum S, Abouelela A, Mekhael W, Ahmed Z. Transspinal direct current stimulation modulates migration and proliferation of adult newly born spinal cells in mice. J Appl Physiol (1985). 2017 Feb 1;122(2):339-353. doi: 10.1152/japplphysiol.00834.2016. Epub 2016 Dec 8.
Results Reference
background
PubMed Identifier
20153248
Citation
Winkler T, Hering P, Straube A. Spinal DC stimulation in humans modulates post-activation depression of the H-reflex depending on current polarity. Clin Neurophysiol. 2010 Jun;121(6):957-61. doi: 10.1016/j.clinph.2010.01.014. Epub 2010 Feb 11.
Results Reference
background
PubMed Identifier
24970753
Citation
Bocci T, Vannini B, Torzini A, Mazzatenta A, Vergari M, Cogiamanian F, Priori A, Sartucci F. Cathodal transcutaneous spinal direct current stimulation (tsDCS) improves motor unit recruitment in healthy subjects. Neurosci Lett. 2014 Aug 22;578:75-9. doi: 10.1016/j.neulet.2014.06.037. Epub 2014 Jun 23.
Results Reference
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PubMed Identifier
21576030
Citation
Truini A, Vergari M, Biasiotta A, La Cesa S, Gabriele M, Di Stefano G, Cambieri C, Cruccu G, Inghilleri M, Priori A. Transcutaneous spinal direct current stimulation inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. Eur J Pain. 2011 Nov;15(10):1023-7. doi: 10.1016/j.ejpain.2011.04.009. Epub 2011 May 14.
Results Reference
background
PubMed Identifier
18786856
Citation
Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.
Results Reference
background
PubMed Identifier
32232101
Citation
Paget-Blanc A, Chang JL, Saul M, Lin R, Ahmed Z, Volpe BT. Non-invasive treatment of patients with upper extremity spasticity following stroke using paired trans-spinal and peripheral direct current stimulation. Bioelectron Med. 2019 Jul 23;5:11. doi: 10.1186/s42234-019-0028-9. eCollection 2019.
Results Reference
derived

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The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

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