WithdrawnNCT03076632Updated Sep 28, 2017

Interactions Between Neurostimulation and Physical Exercise

An interventional study of Cervical plus transcranial stimulation and Cervical stimulation plus hand/wrist exercise in Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, sponsored by Bronx VA Medical Center. Withdrawn. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by Bronx VA Medical Center · Not applicable, Interventional, and Device feasibility

Why this study was withdrawn

Funding obtained to conduct expanded study - to be posted to ClinicalTrials.gov.

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Non-randomized
Ages: 21 Years to 65 Years
Sex: All

Study 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.
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.

Conditions studied

Spinal Cord Injuries
Amyotrophic Lateral Sclerosis

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Keywords

transcranial magnetic stimulation
neurostimulation
non-invasive stimulation
closed-loop stimulation

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

Browse Spinal Cord Injuries studies →

Lead sponsor

Bronx VA Medical Center is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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);
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.

Study design

Phase: Not applicable
Primary purpose: Device feasibility
Allocation: Non-randomized
Intervention model: Crossover assignment
Masking: Single (Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Active comparator
Non-disabled volunteers
Volunteers without neurological injury. Interventions: * Cervical plus transcranial stimulation * Cervical stimulation plus hand/wrist exercise * Electromyographic (EMG)-triggered (closed-loop) stimulation
Device: Cervical plus transcranial stimulation · Device: Cervical stimulation plus hand/wrist exercise · Device: Electromyographic (EMG)-triggered (closed-loop) stimulation
Active comparator
Spinal cord injury
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
Device: Cervical plus transcranial stimulation · Device: Cervical stimulation plus hand/wrist exercise · Device: Electromyographic (EMG)-triggered (closed-loop) stimulation
Active comparator
Amyotrophic lateral sclerosis
Volunteers with amyotrophic lateral sclerosis. Interventions: * Cervical plus transcranial stimulation * Cervical stimulation plus hand/wrist exercise * Electromyographic (EMG)-triggered (closed-loop) stimulation
Device: Cervical plus transcranial stimulation · Device: Cervical stimulation plus hand/wrist exercise · Device: Electromyographic (EMG)-triggered (closed-loop) stimulation

Interventions

DeviceCervical plus transcranial stimulation
Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.
DeviceCervical stimulation plus hand/wrist exercise
Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.
DeviceElectromyographic (EMG)-triggered (closed-loop) stimulation
Force and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation.

What researchers measure

Primary outcomes

Motor evoked potentials (MEP)
Change in MEP amplitude of hand and wrist muscles in response to conditioned versus unconditioned pulses of TMS
Time frame: 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
Time frame: 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.
Time frame: Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03076632
Lead sponsor: Bronx VA Medical Center
Responsible party: Noam Y. Harel, MD, PhD (Staff Physician, Bronx VA Medical Center) — Principal investigator
First posted: Mar 10, 2017
Start date: Apr 1, 2017 (estimated)
Primary completion: Sep 26, 2017
Completion: Sep 26, 2017 (estimated)
Last update: Sep 28, 2017

Study contacts

Noam Y. Harel, MD, PhD

principal investigator · James J. Peters VAMC

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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