NCT03076632

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

February 23, 2017

Last Update Submit

September 26, 2017

Conditions

Spinal Cord InjuriesAmyotrophic Lateral Sclerosis

Keywords

transcranial magnetic stimulationneurostimulationnon-invasive stimulationclosed-loop stimulation

Outcome Measures

Primary Outcomes (3)

  • Motor evoked potentials (MEP)

    Change in MEP amplitude of hand and wrist muscles in response to conditioned versus unconditioned pulses of TMS

    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

    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.

    Four visits (3 for non-disabled volunteers) taking place over 2 to 6 weeks.

Study Arms (3)

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

Device: Cervical plus transcranial stimulationDevice: Cervical stimulation plus hand/wrist exerciseDevice: 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

Device: Cervical plus transcranial stimulationDevice: Cervical stimulation plus hand/wrist exerciseDevice: 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

Device: Cervical plus transcranial stimulationDevice: Cervical stimulation plus hand/wrist exerciseDevice: Electromyographic (EMG)-triggered (closed-loop) stimulation

Interventions

Cervical plus transcranial stimulationDEVICE

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

Amyotrophic lateral sclerosisNon-disabled volunteersSpinal cord injury
Cervical stimulation plus hand/wrist exerciseDEVICE

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

Amyotrophic lateral sclerosisNon-disabled volunteersSpinal cord injury
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.

Amyotrophic lateral sclerosisNon-disabled volunteersSpinal cord injury

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord InjuriesAmyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Noam Y. Harel, MD, PhD

    James J. Peters VAMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Raw electromyography data assessed while masked to specific conditions.
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: Each subject will receive combinations of brain stimulation, cervical stimulation, or peripheral nerve stimulation, either with or without performing simultaneous hand exercises.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 10, 2017

Study Start

April 1, 2017

Primary Completion

September 26, 2017

Study Completion

September 26, 2017

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

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.