Spinal Cord Injury (SCI)NCT02469675
Brain and Nerve Stimulation for Hand Muscles in Spinal Cord Injury and ALS
A study testing Transcranial magnetic stimulation, Median nerve stimulation and Cervical transcutaneous stimulation in people with Spinal Cord Injury (SCI) and Amyotrophic Lateral Sclerosis (ALS), run by Bronx VA Medical Center at 1 site in United States.
Trial summary
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may be an important method to improve functional recovery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spinal Cord Injury (SCI), Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Transcranial magnetic stimulation, Median nerve stimulation and Cervical transcutaneous stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age 21-65 years;
- No history of serious neurological injury or disease; OR
- Chronic (>12 months since injury) incomplete SCI between levels C2-C8 or diagnosis of definite or probable ALS;
- Incomplete weakness of left or right hand muscles: score of 3 or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction;
- Detectable F-wave responses of the left or right abductor pollicis brevis muscle to median nerve stimulation;
- Detectable motor evoked potentials in left or right abductor pollicis brevis muscle to transcranial magnetic stimulation.
Who cannot join
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of moderate to 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);
Show all 16Show fewer
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
- Significant coronary artery or cardiac conduction disease;
- Recurrent history over the last 6 months of autonomic dysreflexia;
- History of bipolar disorder;
- History of suicide attempt;
- Active psychosis;
- Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours;
- Open skin lesions over the face, neck, shoulders, or arms;
- Pregnancy;
- Unsuitable for study participation as determined by study physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: Paired Stimulation to Increase Cortical Transmission to Hand Muscles: Pilot Study
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may be an important method to improve functional recovery.
In this study, the investigators aim to use non-invasive magnetic and electrical stimulation to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used over the motor cortex (scalp). Two methods of electrical stimulation will be compared: stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal cord across the skin on the back of the neck. Several different combinations of magnetic and electrical stimulation will be compared to find the conditions that best strengthen nerve circuits between the brain and hands - "Fire Together, Wire Together".
PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS STUDY. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.
Read the detailed description
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits represents a critical method to improve functional recovery. Different forms of magnetic and electrical stimulation have been used to activate brain, spinal cord, nerve, or muscle tissue. Although in some cases, surgically implanted electrical stimulation has delivered tremendous benefit, a non-invasive approach to nerve stimulation is preferable.
In this proposed study, the investigators aim to use non-invasive magnetic and electrical stimulation to strengthen motor circuits between the brain and hands. Transcranial magnetic stimulation (TMS) will be combined with either electrical stimulation of the median nerve at the wrist; or electrical transcutaneous stimulation of the cervical spinal cord. Magnetic and electrical stimulation will be precisely timed so that the pulses arrive at the target spinal motor neurons at roughly the same time - this precise timing is responsible for the phenomenon of "spike timing-dependent plasticity".
Three groups of participants will be studied: individuals with chronic incomplete cervical SCI (n=12), individuals with definite or probable ALS (n=6), and individuals without neurological injury or disease (n=12). Subjects with SCI or ALS will have one screening visit to confirm eligibility for the study. All subjects will then undergo one baseline testing session followed by 7 sessions of unpaired or paired magnetic and electrical stimulation. Functional and physiological testing will be conducted prior to each stimulation session, then at 0, 15, 30, and 90 minutes post each session. Key measures include grip strength dynamometry, timed performance on a hand dexterity test, amplitude of abductor pollicis brevis (APB) response to TMS, integrated amplitude of APB F-wave responses, and duration of the 'cortical silent period' after TMS stimulation during APB contraction.
PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS STUDY. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.
- Being tested
- Transcranial magnetic stimulation, Median nerve stimulation, Cervical transcutaneous stimulation
- Keywords
- Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Transcranial magnetic stimulation, single pulse, non-invasive brain stimulation
- Medical subject headings
- Spinal Cord Injuries, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Also called MagPro R30
One TMS pulse every 10 seconds for 20 minutes
Median nerve stimulationDevice
Also called Digitimer DS7A
One median nerve pulse every 10 seconds for 20 minutes
Cervical transcutaneous stimulationDevice
Also called Digitimer DS7A
One cervical pulse every 10 seconds for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects undergo same full protocol, including different combinations of stimulation on different days:
Transcranial Magnetic Stimulation Cervical Transcutaneous Stimulation Median Nerve Stimulation Receives: Device: Transcranial magnetic stimulation; Device: Median nerve stimulation; Device: Cervical transcutaneous stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor evoked potential (MEP) amplitude of the abductor pollicis brevis (APB) muscle response to single pulses of TMS
Measured: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Hand dexterity
Timed performance on a grooved pegboard task.
Measured: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Safety and tolerability
Vital signs are monitored throughout procedure; symptoms and degree of pain/discomfort are checked frequently.
Measured: Assessed periodically during each session.
Secondary outcomes (3)
Grip strength
Strength will be quantified using hand-held wireless dynamometry.
Measured: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Change in the duration of the 'cortical silent period' after TMS stimulation during APB contraction
Measured: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
F-wave responses of the APB muscle
Measured: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Noam Y. Harel, MD, PhD, Bronx VA Medical Center
- Investigators
- Noam Y. Harel, MD, PhD, Principal investigator, James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469675
- Sponsor's protocol ID
- HAR-15-001
- Status last verified
- Sep 2018
- First submitted
- 9 Jun 2015
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A Limited Dataset (LDS) will be shared in electronic format pursuant to a VA-approved Data Use Agreement. 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 as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Stimulation to Increase Cortical Transmission to Hand Muscles: Pilot Study
- ClinicalTrials.gov ID
- NCT02469675
- Acronym / sponsor ID
- HAR-15-001
- Keywords
- Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Transcranial magnetic stimulation, single pulse, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- Jun 2015
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may be an important method to improve functional recovery.
In this study, the investigators aim to use non-invasive magnetic and electrical stimulation to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used over the motor cortex (scalp). Two methods of electrical stimulation will be compared: stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal cord across the skin on the back of the neck. Several different combinations of magnetic and electrical stimulation will be compared to find the conditions that best strengthen nerve circuits between the brain and hands - "Fire Together, Wire Together".
PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS STUDY. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.
Detailed description
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits represents a critical method to improve functional recovery. Different forms of magnetic and electrical stimulation have been used to activate brain, spinal cord, nerve, or muscle tissue. Although in some cases, surgically implanted electrical stimulation has delivered tremendous benefit, a non-invasive approach to nerve stimulation is preferable.
In this proposed study, the investigators aim to use non-invasive magnetic and electrical stimulation to strengthen motor circuits between the brain and hands. Transcranial magnetic stimulation (TMS) will be combined with either electrical stimulation of the median nerve at the wrist; or electrical transcutaneous stimulation of the cervical spinal cord. Magnetic and electrical stimulation will be precisely timed so that the pulses arrive at the target spinal motor neurons at roughly the same time - this precise timing is responsible for the phenomenon of "spike timing-dependent plasticity".
Three groups of participants will be studied: individuals with chronic incomplete cervical SCI (n=12), individuals with definite or probable ALS (n=6), and individuals without neurological injury or disease (n=12). Subjects with SCI or ALS will have one screening visit to confirm eligibility for the study. All subjects will then undergo one baseline testing session followed by 7 sessions of unpaired or paired magnetic and electrical stimulation. Functional and physiological testing will be conducted prior to each stimulation session, then at 0, 15, 30, and 90 minutes post each session. Key measures include grip strength dynamometry, timed performance on a hand dexterity test, amplitude of abductor pollicis brevis (APB) response to TMS, integrated amplitude of APB F-wave responses, and duration of the 'cortical silent period' after TMS stimulation during APB contraction.
PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS STUDY. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Transcranial magnetic stimulation, Device: Median nerve stimulation, Device: Cervical transcutaneous stimulationAll subjects undergo same full protocol, including different combinations of stimulation on different days: Transcranial Magnetic Stimulation Cervical Transcutaneous Stimulation Median Nerve Stimulation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females age 21-65 years;
- No history of serious neurological injury or disease; OR
- Chronic (>12 months since injury) incomplete SCI between levels C2-C8 or diagnosis of definite or probable ALS;
- Incomplete weakness of left or right hand muscles: score of 3 or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction;
- Detectable F-wave responses of the left or right abductor pollicis brevis muscle to median nerve stimulation;
Key exclusion criteria (16 listed)
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
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 |
|---|---|---|
| Transcranial magnetic stimulationAlso: MagPro R30One TMS pulse every 10 seconds for 20 minutes | Device | All subjects |
| Median nerve stimulationAlso: Digitimer DS7AOne median nerve pulse every 10 seconds for 20 minutes | Device | All subjects |
| Cervical transcutaneous stimulationAlso: Digitimer DS7AOne cervical pulse every 10 seconds for 20 minutes | Device | All subjects |
Primary outcome
Change in motor evoked potential (MEP) amplitude of the abductor pollicis brevis (APB) muscle response to single pulses of TMS
Time frame: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Hand dexterity
Time frame: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Timed performance on a grooved pegboard task.
Safety and tolerability
Time frame: Assessed periodically during each session.
Vital signs are monitored throughout procedure; symptoms and degree of pain/discomfort are checked frequently.
3 secondary outcomes
Grip strength
Time frame: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Change in the duration of the 'cortical silent period' after TMS stimulation during APB contraction
Time frame: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
F-wave responses of the APB muscle
Time frame: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: Yes. A Limited Dataset (LDS) will be shared in electronic format pursuant to a VA-approved Data Use Agreement. 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 as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.
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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.
Noam Y. Harel, MD, PhD principal investigator
James J. Peters VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation, Median nerve stimulation and Cervical transcutaneous stimulation in people with Spinal Cord Injury (SCI) and Amyotrophic Lateral Sclerosis (ALS), run by Bronx VA Medical Center at 1 site 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 6 inclusion and 16 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 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in motor evoked potential (MEP) amplitude of the abductor pollicis brevis (APB) muscle response to single pulses of TMS (time frame: Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2018.