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Conditioning Neural Circuits to Improve Upper Extremity Function

Primary Purpose

Spinal Cord Injury, Tetraplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
peripheral nerve somatosensory stimulation
sham transcranial direct current stimulation
Sponsored by
Shepherd Center, Atlanta GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be 18-65 years of age
  • Have a cervical (neurological level C1-C8) SCI that occurred either <6 months ago (subacute) or >1 year (chronic) prior to the time of enrollment
  • For subjects with acute/subacute SCI: the injury must be a traumatic injury (i.e. not the result of illness or a condition within the body)
  • Have ISNCSCI severity classification (A, B, C or D)
  • Have self-reported limitations in arm and hand function in at least one upper limb (a GRASSP quantitative score of no more than 26/30 in the hand that is the focus of treatment)
  • Have the ability to pick up objects with at least one hand without using assistive devices (a GRASSP quantitative score of at least 4/30 in the hand that is the focus of treatment)
  • Have shoulder strength lift an arm up to chest level
  • Have the ability to sit for at least one hour at a time (e.g. good skin integrity, stable blood pressure)
  • For subjects with acute/subacute SCI: adequate time remaining in their treatment at Shepherd Center to allow 5 weeks of participation
  • For subjects with chronic SCI: active hand function is required (see Pre-intervention assessment) reliable transportation in order to complete the intervention in its entirety
  • Ability and willingness to consent and authorize use of personal health information

Exclusion Criteria:

  • Pacemaker or a metal implant in the head
  • Current pregnancy
  • Severe shoulder weakness, injury, or pain that contraindicates repetitive fine motor training
  • Lower motor neuron damage (as documented in medical record, per participant report, or as noted by in-person screening)
  • Severe hypersensitivity or pain of the arm/hand
  • Severe contractures of the arm/hand that would limit participation in fine motor training
  • Prior tendon or nerve transfer surgery
  • Have a history of seizures
  • Have a history of frequent or severe headaches

Sites / Locations

  • Shepherd Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

tDCS + FTP group

PNSS + FTP group

sham tDCS + FTP group

Arm Description

This group of individuals with tetraplegia will receive transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1). Stimulation at 2mA will be applied for 20 minutes while subjects complete a total of 1 hour of functional task practice (FTP) per session. (Only 20 minutes of functional task practice be be performed with stimulation on). 3 sessions will be completed per week for 4 weeks.

This group of individuals with tetraplegia will receive peripheral nerve somatosensory stimulation (PNSS) to the median nerve of the primary hand being trained. Stimulation will be set to elicit a sensory - not motor - response. Stimulation will be performed concurrently with the entire functional task practice (FTP) session. 3 sessions will be completed per week for 4 weeks.

This group of individuals with tetraplegia will receive sham transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1) alongside functional task practice. Stimulation will be briefly turned on at the beginning of FTP and again after 20 minutes of practice in order to create a sham effect and maintain blinding of the participants. 3 sessions will be completed per week for 4 weeks.

Outcomes

Primary Outcome Measures

Change in Quantitative Prehension Ability (GRASSP subtest)
Pre-, post-, and follow-up upper extremity impairment and function

Secondary Outcome Measures

Change in Upper Extremity Strength (Grip and Pinch Strength)
Pre-, post-, and follow-up upper extremity impairment and function
Change in Upper Extremity Sensation (Semmes-Weinstein)
Pre-, post-, and follow-up upper extremity impairment and function
Change in Perceived Upper Extremity Performance & Satisfaction (COPM)
Pre-, post-, and follow-up self-perceived upper extremity function
Short-term change in Quantitative Prehension Ability (Abbreviated GRASSP) subtest)
weekly assessment of upper extremity function
Classification of Upper Extremity Function (BHUEF)
Pre-, post-, and follow-up upper extremity impairment and function
Detection of Hand Muscle Activation (subclinical EMG)
Pre-, post-, and follow-up upper extremity impairment and function
Change in Perceived Quality of Life (SCI QoL Basic Data Set)
Pre-, post-, and follow-up self-perceived quality of life rating
Change in Cortical Excitability (motor evoked potentials)
Pre-, post-, and follow-up neural excitability
Change in Spinal Reflex Excitability (joint threshold angle)
Pre-, post-, and follow-up neural excitability

Full Information

First Posted
November 18, 2015
Last Updated
July 27, 2020
Sponsor
Shepherd Center, Atlanta GA
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02611375
Brief Title
Conditioning Neural Circuits to Improve Upper Extremity Function
Official Title
Conditioning Neural Circuits to Improve Upper Extremity Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shepherd Center, Atlanta GA
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Non-invasive brain stimulation has gained increasing popularity and research support over the past several years. Recent research indicates that it might have benefits for improving hand function in people with spinal cord injury. The purpose of this study is to evaluate the effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.
Detailed Description
Transcranial direct current stimulation (tDCS) is a technique in which low intensity electrical current is applied over the skull in order to excite the underlying brain tissue. It has been studied in many populations (stroke, spinal cord injury, learning disability, migraine, memory) and may be a useful counterpart to traditional rehabilitation of neurological injuries. Preliminary studies from members of the investigator's lab group have indicated beneficial, single-session effects of tDCS on hand function in people with spinal cord injury. Longer-term, multi-session trials are now warranted. Another approach that has research support for augmenting the effects of hand function training is peripheral nerve somatosensory stimulation (PNSS). Unlike tDCS, which excites brain tissue directly, PNSS excites the brain via an indirect approach. Members of the investigators' lab have found the combination of PNSS and fine motor training to be more effective in improving hand function than either intervention alone. Multi-session trials of PNSS have been conducted; however it has not yet been compared with another clinically accessible adjunctive therapy, like tDCS, in a multi-session trial. The investigators plan to study the comparative effects of tDCS and hand function training to PNSS and hand function training and hand function training alone in people with neck-level spinal cord injuries. People with both acute/subacute (<6 months post-injury) and chronic (>1 year post-injury) injuries will be enrolled, in order to look at responses to tDCS at different stages of recovery. Before beginning training, participants will complete approximately three hours of testing of their arm/hand function and self-reported perception of their overall function. Participants will then be randomly assigned to receive either tDCS, PNSS, or sham tDCS in combination with personalized fine motor training. This training will take place 3 times/week, for a total of 3 hours of training/week, for 4 weeks. Fine motor training will be based on principles that have been shown to optimize neuroplasticity (changes in the brain and/or spinal cord), yet customized, in order to allow participants to work towards individualized goals. At the end of 4 weeks, participants will complete a three-hour post-test using the same measures as before to examine any changes in arm and hand function. Participants will be asked to return to Shepherd Center 4 - 6 weeks following the post-intervention assessment to complete the post-intervention assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Tetraplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS + FTP group
Arm Type
Experimental
Arm Description
This group of individuals with tetraplegia will receive transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1). Stimulation at 2mA will be applied for 20 minutes while subjects complete a total of 1 hour of functional task practice (FTP) per session. (Only 20 minutes of functional task practice be be performed with stimulation on). 3 sessions will be completed per week for 4 weeks.
Arm Title
PNSS + FTP group
Arm Type
Active Comparator
Arm Description
This group of individuals with tetraplegia will receive peripheral nerve somatosensory stimulation (PNSS) to the median nerve of the primary hand being trained. Stimulation will be set to elicit a sensory - not motor - response. Stimulation will be performed concurrently with the entire functional task practice (FTP) session. 3 sessions will be completed per week for 4 weeks.
Arm Title
sham tDCS + FTP group
Arm Type
Active Comparator
Arm Description
This group of individuals with tetraplegia will receive sham transcranial direct current stimulation (tDCS) over the hand area of their primary motor cortex (M1) alongside functional task practice. Stimulation will be briefly turned on at the beginning of FTP and again after 20 minutes of practice in order to create a sham effect and maintain blinding of the participants. 3 sessions will be completed per week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
High-definition transcranial direct current stimulation is applied over the hand area of the primary motor cortex (M1). Parameters= 2mA for 20 minutes. Functional task practice will be completed concurrently with tDCS and for approximate 40 minutes after the stimulation stops.
Intervention Type
Other
Intervention Name(s)
peripheral nerve somatosensory stimulation
Intervention Description
Electrical stimulation will be applied to the median nerve of the primary hand being trained at parameters that elicit a sensory but not motor response (called "peripheral nerve somatosensory stimulation"). Stimulation parameters are 100Hz with a 250uS pulse width. Stimulation intensity will vary between 1-10mA per participant. Stimulation will be applied for 1 hour and functional task practice will be completed concurrent with the stimulation.
Intervention Type
Other
Intervention Name(s)
sham transcranial direct current stimulation
Intervention Description
During sham transcranial direct current stimulation (tDCS), a sham tDCS device will be used along with functional task practice. The sham tDCS unit will be used for the first 20 minutes of FTP, followed by an additional 40 minutes of FTP.
Primary Outcome Measure Information:
Title
Change in Quantitative Prehension Ability (GRASSP subtest)
Description
Pre-, post-, and follow-up upper extremity impairment and function
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in Upper Extremity Strength (Grip and Pinch Strength)
Description
Pre-, post-, and follow-up upper extremity impairment and function
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Change in Upper Extremity Sensation (Semmes-Weinstein)
Description
Pre-, post-, and follow-up upper extremity impairment and function
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Change in Perceived Upper Extremity Performance & Satisfaction (COPM)
Description
Pre-, post-, and follow-up self-perceived upper extremity function
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Short-term change in Quantitative Prehension Ability (Abbreviated GRASSP) subtest)
Description
weekly assessment of upper extremity function
Time Frame
weekly during 4-week treatment period
Title
Classification of Upper Extremity Function (BHUEF)
Description
Pre-, post-, and follow-up upper extremity impairment and function
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Detection of Hand Muscle Activation (subclinical EMG)
Description
Pre-, post-, and follow-up upper extremity impairment and function
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Change in Perceived Quality of Life (SCI QoL Basic Data Set)
Description
Pre-, post-, and follow-up self-perceived quality of life rating
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Change in Cortical Excitability (motor evoked potentials)
Description
Pre-, post-, and follow-up neural excitability
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention
Title
Change in Spinal Reflex Excitability (joint threshold angle)
Description
Pre-, post-, and follow-up neural excitability
Time Frame
Baseline, 1 week post-intervention, 4-6 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be 18-65 years of age Have a cervical (neurological level C1-C8) SCI that occurred either <6 months ago (subacute) or >1 year (chronic) prior to the time of enrollment For subjects with acute/subacute SCI: the injury must be a traumatic injury (i.e. not the result of illness or a condition within the body) Have ISNCSCI severity classification (A, B, C or D) Have self-reported limitations in arm and hand function in at least one upper limb (a GRASSP quantitative score of no more than 26/30 in the hand that is the focus of treatment) Have the ability to pick up objects with at least one hand without using assistive devices (a GRASSP quantitative score of at least 4/30 in the hand that is the focus of treatment) Have shoulder strength lift an arm up to chest level Have the ability to sit for at least one hour at a time (e.g. good skin integrity, stable blood pressure) For subjects with acute/subacute SCI: adequate time remaining in their treatment at Shepherd Center to allow 5 weeks of participation For subjects with chronic SCI: active hand function is required (see Pre-intervention assessment) reliable transportation in order to complete the intervention in its entirety Ability and willingness to consent and authorize use of personal health information Exclusion Criteria: Pacemaker or a metal implant in the head Current pregnancy Severe shoulder weakness, injury, or pain that contraindicates repetitive fine motor training Lower motor neuron damage (as documented in medical record, per participant report, or as noted by in-person screening) Severe hypersensitivity or pain of the arm/hand Severe contractures of the arm/hand that would limit participation in fine motor training Prior tendon or nerve transfer surgery Have a history of seizures Have a history of frequent or severe headaches
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edelle C Field-Fote, PT, PhD
Organizational Affiliation
Shepherd Center, Atlanta GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shepherd Center, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20633386
Citation
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
Results Reference
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PubMed Identifier
23796102
Citation
Gomes-Osman J, Field-Fote EC. Bihemispheric anodal corticomotor stimulation using transcranial direct current stimulation improves bimanual typing task performance. J Mot Behav. 2013;45(4):361-7. doi: 10.1080/00222895.2013.808604. Epub 2013 Jun 24.
Results Reference
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PubMed Identifier
15672628
Citation
Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
Results Reference
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Citation
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Results Reference
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Citation
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Conditioning Neural Circuits to Improve Upper Extremity Function

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