Spinal Cord InjuryNCT01915095

Improving Motor Function After Spinal Cord Injury

A study testing rTMS, Training and Motor Task in people with Spinal Cord Injury, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Spinal Cord Injury
What is being tested?: rTMS, Training and Motor Task
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 3 sitesUnited States
Study dates: 1 Sep 2017to 1 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 17Show fewer

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)
The ability to perform a small visible contraction with dorsiflexor and hip flexor muscles
No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status.

Who cannot join

Exclusion criteria for enrollment For SCI and Healthy Control Subjects (for stimulation):
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

Show all 11Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Official title: Enhancement of Hand Motor Function After Cervical Spinal Cord Injury

Read the detailed description

This study will consist of electromyography (surface and intramuscular), peripheral nerve stimulation, and transcranial magnetic stimulation, electrical stimulation, of the hand, arm, leg, and foot representation of the primary motor cortex, as well as MRI scans of the brain. The investigators will examine the physiological measurements of upper and lower extremity muscles (such as in the first dorsal interosseous (FDI), biceps brachii (BIC), anterior deltoid (AD), tibialis anterior (TA), hamstring (HAMS) and quadriceps (QUAD)). This study may occur at the Miami Project to cure Paralysis at the University of Miami. The investigators will include subjects between the ages of 18 and 85, both healthy controls and individuals with chronic spinal cord injuries that occurred at least 6 months prior to recruitment. Both healthy controls and those with spinal cord injuries will be able to perform small hand and arm movements and small leg and foot movements. The primary outcome measures of this study are muscle responses to stimulation with magnetic pulses using TMS and electrical stimulation of a peripheral nerve in the arm or leg. The investigators propose to enhance the recovery of motor function by using new protocols of high frequency non-invasive repetitive TMS (rTMS) and motor training. Repetitive TMS will be used during hand, arm, leg and foot movements in a task-dependent manner to induce cortical plasticity and enhance voluntary output of the muscles associated with those movements. Second, rTMS will be applied in a task-dependent manner during a visuo-motor training task that also involves movements of the hands, arms, legs or feet.

Conditions: Spinal Cord Injury
Being tested: rTMS, Sham rTMS, Training, Motor Task
Keywords: spinal cord injury, neural control, motor function, hand movement
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rTMSDevice
small magnetic pulses will be given to the brain in a non invasive manner.
Sham rTMSDevice
sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
TrainingOther
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
Motor TaskOther
participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.

Study groups in NCT01915095
Study group	Role	What they receive
Motor task+ Magnetic stimulation	Active comparator	Participants 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. Receives: Device: rTMS; Device: Sham rTMS; Other: Motor Task
rTMS/sham rTMS	Active comparator	Participant 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. Receives: Device: rTMS; Device: Sham rTMS
Training + rTMS/ Sham rTMS	Active comparator	Participants 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. Receives: Device: rTMS; Device: Sham rTMS; Other: Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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 is a standardized test of several major aspects of hand function using simulated activities of daily living (writing, picking up small objects, picking up heavy objects etc.). The time taken to perform simulated activities of daily living is assessed. Lesser time to perform the activities would be considered a better outcome.
Measured: The JTT was measured at Baseline, Post 5 training sessions, and Post all training sessions at each 2-hour session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20171 Sep 2019

First posted2 Aug 2013 (estimated)
Study start1 Sep 2017
Primary completion1 Sep 2019
Study completion1 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01915095
Sponsor's protocol ID: B0815-R
Status last verified: May 2021
First submitted: 19 Jul 2013
Last updated: 11 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancement of Hand Motor Function After Cervical Spinal Cord Injury
ClinicalTrials.gov ID: NCT01915095
Acronym / sponsor ID: B0815-R
Conditions: Spinal Cord Injury
Keywords: spinal cord injury, neural control, motor function, hand movement
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Sep 2017 (actual)
Primary completion: 1 Sep 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 2 Aug 2013 (estimated)
Results: Posted 4 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Motor task+ Magnetic stimulation	Active comparator	Device: rTMS, Device: Sham rTMS, Other: Motor TaskParticipants 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 comparator	Device: rTMS, Device: Sham rTMSParticipant 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 comparator	Device: rTMS, Device: Sham rTMS, Other: TrainingParticipants 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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.
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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rTMSsmall magnetic pulses will be given to the brain in a non invasive manner.	Device	Motor task+ Magnetic stimulation, Training + rTMS/ Sham rTMS, rTMS/sham rTMS
Sham rTMSsham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner	Device	Motor task+ Magnetic stimulation, Training + rTMS/ Sham rTMS, rTMS/sham rTMS
Trainingat 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	Other	Training + rTMS/ Sham rTMS
Motor Taskparticipants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.	Other	Motor task+ Magnetic stimulation

Primary outcome

Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS
Time frame: Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60
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.
Electromyography (EMG)
Time frame: Before and After the stimulation during each 2-hour session (rTMS/Sham rTMS/Sham rTMS over control brain area)
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.

1 secondary outcome

The Jebsen Taylor Hand Function Test (JTT)
Time frame: The JTT was measured at Baseline, Post 5 training sessions, and Post all training sessions at each 2-hour session.

Results and safety

Results posted to the registry on 4 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wrist Flexion and Precision Grip + rTMS and Sham rTMS	10	10
Wrist Extension and Precision Grip + rTMS and Sham rTMS	10	10
rTMS/Sham rTMS/Sham rTMS Over Control Brain Area	5	5
Training + rTMS	8	4
Training + Sham rTMS	9	3

Primary outcome: Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS

Time frame: Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60. Mean (Standard Deviation). Unit: millivolts (mV)

Measure	Wrist Flexion and Precision Grip + rTMS (SCI) n = 5	Wrist Flexion and Precision Grip + Sham rTMS (SCI) n = 5	Wrist Flexion and Precision Grip + rTMS (Control) n = 5	Wrist Flexion and Precision Grip + Sham rTMS (Control) n = 5	Wrist Extension and Precision Grip + rTMS (SCI) n = 5	Wrist Extension and Precision Grip + Sham rTMS (SCI) n = 5	Wrist Extension and Precision Grip + rTMS (Control) n = 5	Wrist Extension and Precision Grip + Sham rTMS (Control) n = 5	rTMS/Sham rTMS/Sham rTMS Over Control Brain Area n = 5	Training + rTMS n = 4	Training + Sham rTMS n = 3
Before: minute 0	0.31 (0.52)	0.43 (0.77)	0.45 (0.81)	0.65 (1.12)	0.33 (0.92)	0.44 (0.61)	0.59 (0.98)	0.52 (0.83)	–	–	–
Before: minute 10	0.33 (0.56)	0.39 (0.88)	0.47 (1.12)	0.71 (1.08)	0.37 (0.83)	0.46 (0.72)	0.66 (1.02)	0.56 (1.06)	–	–	–
Before: minute 30	0.36 (0.83)	0.41 (0.80)	0.51 (0.52)	0.68 (0.91)	0.42 (1.17)	0.45 (0.93)	0.63 (1.07)	0.53 (0.92)	–	–	–
Before: minute 60	0.39 (1.02)	0.42 (0.65)	0.53 (0.85)	0.72 (1.15)	0.45 (0.98)	0.42 (1.02)	0.65 (0.97)	0.61 (0.82)	–	–	–
After: minute 0	0.36 (1.03)	0.45 (0.81)	0.49 (1.26)	0.66 (0.82)	0.44 (0.67)	0.61 (0.98)	0.66 (1.03)	0.57 (0.91)	–	–	–
After: minute 10	0.35 (0.83)	0.44 (0.79)	0.51 (0.35)	0.71 (1.13)	0.41 (1.02)	0.59 (1.03)	0.71 (0.98)	0.63 (0.70)	–	–	–
After: minute 30	0.50 (1.44)	0.43 (0.61)	0.50 (0.81)	0.73 (0.91)	0.42 (0.91)	0.63 (1.12)	0.72 (1.04)	0.61 (1.02)	–	–	–
After: minute 60	0.55 (1.18)	0.44 (0.71)	0.55 (0.33)	0.74 (0.78)	0.46 (0.88)	0.66 (0.98)	0.74 (1.12)	0.62 (0.87)	–	–	–

Population analysed: The number differs due to different study visits in each arm

Primary outcome: Electromyography (EMG)

Time frame: Before and After the stimulation during each 2-hour session (rTMS/Sham rTMS/Sham rTMS over control brain area). Mean (Standard Deviation). Unit: Millivolts (mV)

Measure	rTMS, Sham rTMS, Sham rTMS Over Control Brain Area n = 5
Session 1: Before	0.138 (0.239)
Session 1: After	0.191 (0.323)
Session 2: Before	0.204 (0.361)
Session 2: After	0.208 (0.384)
Session 3: Before	0.221 (0.329)
Session 3: After	0.231 (0.352)

Population analysed: The EMG measurement was not collected in every study arm, only this arm.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The adverse event data was collected from baseline to completion of study visits for each participant, an average of 6 days for Arm 1 and an average of 3 weeks for Arm 2 and 3.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wrist Flexion and Precision Grip + rTMS and Sham rTMS	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Wrist Extension and Precision Grip + rTMS and Sham rTMS	0 of 10 (0%)	0 of 10 (0%)	0 of 10
rTMS/Sham rTMS/Sham rTMS Over Control Brain Area	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Training + rTMS	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Training + Sham rTMS	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Monica A Perez, PhD principal investigator

Edward Hines Jr. VA Hospital, Hines, IL

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing rTMS, Training and Motor Task in people with Spinal Cord Injury, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiology Measurements Before and After rTMS/Sham rTMS Protocol- Changes in Amplitude of Motor Evoked Potential (MEP) From TMS (time frame: Post rTMS, Sham rTMS, and Sham rTMS over control brain for all sessions at minute 0, 10, 30, and 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01915095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.