Improving Motor Function After Spinal Cord Injury
Enhancement of Hand Motor Function After Cervical Spinal Cord Injury
1 other identifier
interventional
42
1 country
3
Brief Summary
The goals of this study are to examine the physiology of Central Nervous System pathways contributing to the control of upper and lower extremity movements after SCI, and to promote the recovery of extremity movements by using non-invasive brain stimulation and motor training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedJune 11, 2021
May 1, 2021
2 years
July 19, 2013
August 25, 2020
May 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS
For Wrist flexion and precision grip + rTMS/Sham rTMS and Wrist extension and precision grip + rTMS/Sham rTMS we measured the changes in the MEPs before the intervention(rTMS/Sham rTMS) at minute 0, 10, 30, and 60 and then again after at minute 0, 10, 30, and 60. The information below is separated first by wrist flexion or extension, then by study visit (rTMS or Sham rTMS), and finally by subject characteristic (SCI or control). This study is a crossover design, what that means is subjects (SCI and Controls) will participate in both sessions (rTMS and Sham rTMS). For rTMS/Sham rTMS/Sham rTMS over control brain area we measured the changes in the MEPs at minute 0, 10, 30, and 60.The information for this arm is separated by study visit: Session 1 is rTMS, Session 2 is Sham rTMS, and Session 3 is Sham rTMS over control brain area. For Training + rTMS and Training + Sham rTMS we measured the changes in the MEPs at baseline, post 5 training sessions, and post all training sessions.
Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60
Electromyography (EMG)
For rTMS/Sham rTMS/Sham rTMS over control brain area we measured voluntary output in hand muscles using EMG before and after the stimulation.The information for this arm is separated by study visit: Session 1 is rTMS, Session 2 is Sham rTMS, and Session 3 is Sham rTMS over control brain area.
Before and After the stimulation during each 2-hour session (rTMS/Sham rTMS/Sham rTMS over control brain area)
Secondary Outcomes (1)
The Jebsen Taylor Hand Function Test (JTT)
The JTT was measured at Baseline, Post 5 training sessions, and Post all training sessions at each 2-hour session.
Study Arms (3)
Motor task+ Magnetic stimulation
ACTIVE COMPARATORParticipants will be asked to complete a precision grip with the index and thumb finger at the same time as flexing or extending the wrist. magnetic stimulation to the brain will be administered and measurements will be taken during movement.
rTMS/sham rTMS
ACTIVE COMPARATORParticipant will be randomly assigned to one of 3 groups: repetitive transcranial magnetic stimulation (rTMS), sham (fake) rTMS, or sham (fake) rTMS over control brain area will be administered to the brain. the stimulation will be targeting finger and wrist muscles during movement.
Training + rTMS/ Sham rTMS
ACTIVE COMPARATORParticipants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement . Magnetic stimulation will be given during rest and movement.
Interventions
small magnetic pulses will be given to the brain in a non invasive manner.
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training
participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
Eligibility Criteria
You may qualify if:
- Male and female Veterans and non Veterans with spinal cord injury at least 6 months after injury was sustained. The investigators also plan to enroll control subjects who do not have any history of spinal cord injury.
- Participants who are unimpaired healthy controls:
- Male and females between ages 18-85 years
- Right handed
- Able to complete precision grips with both hands
- Able to complete full wrist flexion-extension bilaterally
- Able to walk unassisted
- Able to complete full ankle flexion-extension bilaterally
- Participants who have had a spinal cord injury:
- Male and females between ages 18-85 years
- Chronic SCI ( 6 months of injury)
- Spinal Cord injury at or above L5
- The ability to produce a visible precision grip force with one hand
- Individuals who have the ability to pick up a small object (large paperclip) from a table independently
- Able to perform some small wrist flexion and extension (measured by a goniometer)
- +2 more criteria
You may not qualify if:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
- Pregnant females
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated cervical disk
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Audrey Wilson
- Organization
- Hines VA
Study Officials
- PRINCIPAL INVESTIGATOR
Monica A Perez, PhD
Edward Hines Jr. VA Hospital, Hines, IL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2013
First Posted
August 2, 2013
Study Start
September 1, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
June 11, 2021
Results First Posted
November 4, 2020
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share