NCT02469675

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

3.2 years

First QC Date

June 9, 2015

Last Update Submit

September 28, 2018

Conditions

Spinal Cord Injury (SCI)Amyotrophic Lateral Sclerosis (ALS)

Keywords

Spinal Cord InjuriesAmyotrophic Lateral SclerosisTranscranial magnetic stimulation, single pulsenon-invasive brain stimulation

Outcome Measures

Primary Outcomes (3)

  • Change in motor evoked potential (MEP) amplitude of the abductor pollicis brevis (APB) muscle response to single pulses of TMS

    Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.

  • Hand dexterity

    Timed performance on a grooved pegboard task.

    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.

    Assessed periodically during each session.

Secondary Outcomes (3)

  • Grip strength

    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

    Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.

  • F-wave responses of the APB muscle

    Assessed pre, then 0, 15, 30, and 90 minutes post-intervention.

Study Arms (1)

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

Device: Transcranial magnetic stimulationDevice: Median nerve stimulationDevice: Cervical transcutaneous stimulation

Interventions

Transcranial magnetic stimulationDEVICE

One TMS pulse every 10 seconds for 20 minutes

Also known as: MagPro R30
All subjects
Median nerve stimulationDEVICE

One median nerve pulse every 10 seconds for 20 minutes

Also known as: Digitimer DS7A
All subjects
Cervical transcutaneous stimulationDEVICE

One cervical pulse every 10 seconds for 20 minutes

Also known as: Digitimer DS7A
All subjects

Eligibility Criteria

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

You may qualify if:

  • 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.

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 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);
  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesAmyotrophic Lateral Sclerosis

Interventions

Transcranial Magnetic Stimulation

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Noam Y. Harel, MD, PhD

    James J. Peters VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 11, 2015

Study Start

June 1, 2015

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

October 1, 2018

Record last verified: 2018-09

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.

Locations

US(1)