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Interactions Between Neurostimulation and Physical Exercise

NCT ID: NCT03076632

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-09-26

Brief Summary

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* 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

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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

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Spinal Cord Injuries Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Each subject will receive combinations of brain stimulation, cervical stimulation, or peripheral nerve stimulation, either with or without performing simultaneous hand exercises.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors
Raw electromyography data assessed while masked to specific conditions.

Study Groups

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Non-disabled volunteers

Volunteers without neurological injury.

Interventions:

* Cervical plus transcranial stimulation
* Cervical stimulation plus hand/wrist exercise
* Electromyographic (EMG)-triggered (closed-loop) stimulation

Group Type ACTIVE_COMPARATOR

Cervical plus transcranial stimulation

Intervention Type DEVICE

Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.

Cervical stimulation plus hand/wrist exercise

Intervention Type DEVICE

Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.

Electromyographic (EMG)-triggered (closed-loop) stimulation

Intervention Type DEVICE

Force and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation.

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

Group Type ACTIVE_COMPARATOR

Cervical plus transcranial stimulation

Intervention Type DEVICE

Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.

Cervical stimulation plus hand/wrist exercise

Intervention Type DEVICE

Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.

Electromyographic (EMG)-triggered (closed-loop) stimulation

Intervention Type DEVICE

Force and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation.

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

Group Type ACTIVE_COMPARATOR

Cervical plus transcranial stimulation

Intervention Type DEVICE

Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.

Cervical stimulation plus hand/wrist exercise

Intervention Type DEVICE

Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.

Electromyographic (EMG)-triggered (closed-loop) stimulation

Intervention Type DEVICE

Force and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation.

Interventions

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Cervical plus transcranial stimulation

Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.

Intervention Type DEVICE

Cervical stimulation plus hand/wrist exercise

Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.

Intervention Type DEVICE

Electromyographic (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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age between 21 and 65 years;
2. Chronic (more than 12 months since injury) incomplete SCI between levels C2-C8 or diagnosis of definite or probable ALS;
3. 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;
4. Detectable F-wave responses of the left or right abductor pollicis brevis muscle to median nerve stimulation.

Exclusion Criteria

1. Multiple spinal cord lesions;
2. History of seizures;
3. Ventilator dependence or patent tracheostomy site;
4. Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
5. History of stroke, brain tumor, brain abscess, or multiple sclerosis;
6. 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);
7. History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
8. Significant coronary artery or cardiac conduction disease;
9. 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);
10. History of bipolar disorder;
11. History of suicide attempt;
12. Active psychosis;
13. Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours;
14. Open skin lesions over the face, neck, shoulders, or arms;
15. Pregnancy
16. Unsuitable for study participation as determined by study physician.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bronx VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Noam Y. Harel, MD, PhD

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noam Y. Harel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters VAMC

Other Identifiers

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HAR-16-042

Identifier Type: -

Identifier Source: org_study_id