Spinal Cord InjuriesNCT03076632
Interactions Between Neurostimulation and Physical Exercise
A study testing Cervical plus transcranial stimulation, Cervical stimulation plus hand/wrist exercise and Electromyographic (EMG)-triggered (closed-loop) stimulation in people with Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, run by Bronx VA Medical Center.
Trial summary
People with cervical spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS) have reduced connections in the nerve circuits between the brain and the hands. Activating spared nerve circuits is one potential way to improve recovery. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Amyotrophic Lateral Sclerosis
- What is being tested?
- Cervical plus transcranial stimulation, Cervical stimulation plus hand/wrist exercise and Electromyographic (EMG)-triggered (closed-loop) stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 26 Sep 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years;
- Chronic (more than 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 2, 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.
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 or 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);
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- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
- Significant coronary artery or cardiac conduction disease;
- Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
- 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.
About this study
Official title: Acute Interactions Between Electromagnetic Stimulation and Physical Exercise
- People with cervical spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS) have reduced connections in the nerve circuits between the brain and the hands. Activating spared nerve circuits is one potential way to improve recovery.
- The investigators are testing different combinations of physical wrist and hand movements paired with magnetic brain stimulation and electrical spinal cord or nerve stimulation to see the effects on nerve transmission to hand muscles.
- This is a preliminary study. This study is testing for temporary changes in nerve transmission to hand muscles. There is no expectation of long-term benefit from this study. If temporary changes are seen in this study, then future studies would focus on how to prolong that effect.
Read the detailed description
Spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS) result in a mixture of destroyed, damaged, and spared neural circuits. Activating spared nerve circuits augments neural transmission.
With this goal in mind, the investigators recently developed a novel method of cervical electrical stimulation (CES) to noninvasively activate arm and hand muscles. The investigators are conducting a pilot clinical study (NCT02469675) to establish CES safety in subjects with cervical SCI, ALS, and non-disabled volunteers. To date, 19 subjects have undergone >120 CES sessions without major safety or tolerability issues.
The current study is designed to gain further mechanistic insight. In Aim 1, the investigators will test in more detail how CES (traveling through spinal and peripheral circuits) interacts with individual pulses of TMS (traveling through corticospinal circuits). In Aim 2, the investigators will further test CES's therapeutic potential by combining stimulation with simultaneous physical exercises. In Aim 3, the investigators will compare the acute effects on synaptic transmission of passive stimulation to stimulation triggered by the subject's own muscle activity.
Please note, this is a preliminary study. This study is testing for temporary changes in nerve transmission to hand muscles. There is no expectation of long-term benefit from this study. If the investigators see temporary changes in this study, then future studies would focus on how to prolong that effect.
- Being tested
- Cervical plus transcranial stimulation, Cervical stimulation plus hand/wrist exercise, Electromyographic (EMG)-triggered (closed-loop) stimulation
- Keywords
- transcranial magnetic stimulation, neurostimulation, non-invasive stimulation, closed-loop 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.
Cervical plus transcranial stimulationDevice
Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.
Cervical stimulation plus hand/wrist exerciseDevice
Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.
Electromyographic (EMG)-triggered (closed-loop) stimulationDevice
Force and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Non-disabled volunteers | Active comparator | Volunteers without neurological injury.
Interventions:
* Cervical plus transcranial stimulation
* Cervical stimulation plus hand/wrist exercise
* Electromyographic (EMG)-triggered (closed-loop) stimulation Receives: Device: Cervical plus transcranial stimulation; Device: Cervical stimulation plus hand/wrist exercise; Device: Electromyographic (EMG)-triggered (closed-loop) stimulation |
| Spinal cord injury | Active comparator | Volunteers with motor-incomplete cervical spinal cord injury.
Interventions:
* Cervical plus transcranial stimulation
* Cervical stimulation plus hand/wrist exercise
* Electromyographic (EMG)-triggered (closed-loop) stimulation Receives: Device: Cervical plus transcranial stimulation; Device: Cervical stimulation plus hand/wrist exercise; Device: Electromyographic (EMG)-triggered (closed-loop) stimulation |
| Amyotrophic lateral sclerosis | Active comparator | Volunteers with amyotrophic lateral sclerosis.
Interventions:
* Cervical plus transcranial stimulation
* Cervical stimulation plus hand/wrist exercise
* Electromyographic (EMG)-triggered (closed-loop) stimulation Receives: Device: Cervical plus transcranial stimulation; Device: Cervical stimulation plus hand/wrist exercise; Device: Electromyographic (EMG)-triggered (closed-loop) stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potentials (MEP)
Change in MEP amplitude of hand and wrist muscles in response to conditioned versus unconditioned pulses of TMS
Measured: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.
Volitional electromyographic (EMG) activity
Change in EMG activity of hand and wrist muscles in response to cervical stimulation during physical activity
Measured: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.
Response to closed-loop stimulation
Transmission of pulses of TMS or peripheral nerve stimulation will be increased when stimulation is triggered by endogenous EMG activity.
Measured: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Apr 2017 (estimated)
- Primary completion26 Sep 2017
- Study completion26 Sep 2017 (estimated)
Why it stopped: Funding obtained to conduct expanded study - to be posted to ClinicalTrials.gov.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each subject will receive combinations of brain stimulation, cervical stimulation, or peripheral nerve stimulation, either with or without performing simultaneous hand exercises.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 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 VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076632
- Sponsor's protocol ID
- HAR-16-042
- Status last verified
- Sep 2017
- First submitted
- 23 Feb 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Interactions Between Electromagnetic Stimulation and Physical Exercise
- ClinicalTrials.gov ID
- NCT03076632
- Acronym / sponsor ID
- HAR-16-042
- Keywords
- transcranial magnetic stimulation, neurostimulation, non-invasive stimulation, closed-loop stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding obtained to conduct expanded study - to be posted to ClinicalTrials.gov.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (estimated)
- First posted
- 10 Mar 2017 (actual)
- 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.
- People with cervical spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS) have reduced connections in the nerve circuits between the brain and the hands. Activating spared nerve circuits is one potential way to improve recovery.
- The investigators are testing different combinations of physical wrist and hand movements paired with magnetic brain stimulation and electrical spinal cord or nerve stimulation to see the effects on nerve transmission to hand muscles.
- This is a preliminary study. This study is testing for temporary changes in nerve transmission to hand muscles. There is no expectation of long-term benefit from this study. If temporary changes are seen in this study, then future studies would focus on how to prolong that effect.
Detailed description
Spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS) result in a mixture of destroyed, damaged, and spared neural circuits. Activating spared nerve circuits augments neural transmission.
With this goal in mind, the investigators recently developed a novel method of cervical electrical stimulation (CES) to noninvasively activate arm and hand muscles. The investigators are conducting a pilot clinical study (NCT02469675) to establish CES safety in subjects with cervical SCI, ALS, and non-disabled volunteers. To date, 19 subjects have undergone >120 CES sessions without major safety or tolerability issues.
The current study is designed to gain further mechanistic insight. In Aim 1, the investigators will test in more detail how CES (traveling through spinal and peripheral circuits) interacts with individual pulses of TMS (traveling through corticospinal circuits). In Aim 2, the investigators will further test CES's therapeutic potential by combining stimulation with simultaneous physical exercises. In Aim 3, the investigators will compare the acute effects on synaptic transmission of passive stimulation to stimulation triggered by the subject's own muscle activity.
Please note, this is a preliminary study. This study is testing for temporary changes in nerve transmission to hand muscles. There is no expectation of long-term benefit from this study. If the investigators see temporary changes in this study, then future studies would focus on how to prolong that effect.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Each subject will receive combinations of brain stimulation, cervical stimulation, or peripheral nerve stimulation, either with or without performing simultaneous hand exercises.
| Arm | Type | Receives |
|---|---|---|
| Non-disabled volunteers | Active comparator | Device: Cervical plus transcranial stimulation, Device: Cervical stimulation plus hand/wrist exercise, Device: Electromyographic (EMG)-triggered (closed-loop) stimulationVolunteers without neurological injury. Interventions: * Cervical plus transcranial stimulation * Cervical stimulation plus hand/wrist exercise * Electromyographic (EMG)-triggered (closed-loop) stimulation |
| Spinal cord injury | Active comparator | Device: Cervical plus transcranial stimulation, Device: Cervical stimulation plus hand/wrist exercise, Device: Electromyographic (EMG)-triggered (closed-loop) stimulationVolunteers with motor-incomplete cervical spinal cord injury. Interventions: * Cervical plus transcranial stimulation * Cervical stimulation plus hand/wrist exercise * Electromyographic (EMG)-triggered (closed-loop) stimulation |
| Amyotrophic lateral sclerosis | Active comparator | Device: Cervical plus transcranial stimulation, Device: Cervical stimulation plus hand/wrist exercise, Device: Electromyographic (EMG)-triggered (closed-loop) stimulationVolunteers with amyotrophic lateral sclerosis. Interventions: * Cervical plus transcranial stimulation * Cervical stimulation plus hand/wrist exercise * Electromyographic (EMG)-triggered (closed-loop) stimulation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 21 and 65 years;
- Chronic (more than 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 2, 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 |
|---|---|---|
| Cervical plus transcranial stimulationConditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation. | Device | Amyotrophic lateral sclerosis, Non-disabled volunteers, Spinal cord injury |
| Cervical stimulation plus hand/wrist exercisePulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks. | Device | Amyotrophic lateral sclerosis, Non-disabled volunteers, Spinal cord injury |
| Electromyographic (EMG)-triggered (closed-loop) stimulationForce and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation. | Device | Amyotrophic lateral sclerosis, Non-disabled volunteers, Spinal cord injury |
Primary outcome
Motor evoked potentials (MEP)
Time frame: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.
Change in MEP amplitude of hand and wrist muscles in response to conditioned versus unconditioned pulses of TMS
Volitional electromyographic (EMG) activity
Time frame: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.
Change in EMG activity of hand and wrist muscles in response to cervical stimulation during physical activity
Response to closed-loop stimulation
Time frame: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.
Transmission of pulses of TMS or peripheral nerve stimulation will be increased when stimulation is triggered by endogenous EMG activity.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- 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 VAMC
Questions about this trial
What is this clinical trial studying?
A study testing Cervical plus transcranial stimulation, Cervical stimulation plus hand/wrist exercise and Electromyographic (EMG)-triggered (closed-loop) stimulation in people with Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, run by Bronx VA Medical Center.
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 4 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: withdrawn, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Motor evoked potentials (MEP) (time frame: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.). 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 28 Sep 2017; AzTrials last refreshed its copy on 27 Oct 2026.