Improving Hand Recovery With Neuromodulation in Tetraplegia

NCT03954496 | Terminated

• 1 other identifier: 201810171642
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.

Conditions

Spinal Cord Injuries; Tetraplegia, Unspecified, Incomplete, Chronic

Keywords

neuroplasticity; rehabilitation; transcranial direct current stimulation; transcranial magnetic stimulation; activities of daily living; motor training

Outcome Measures

Primary Outcomes (1)

• Change in Spinal Cord Independence Measure

  This evaluates self-care, respiration and sphincter management, and mobility.

  Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

Secondary Outcomes (7)

• Change in Medical Research Council Scale Upper Extremity Manual Muscle Test

  Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

• Change in Canadian Occupational Performance Measure

  Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

• Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension

  Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

• Change in Van Lieshout Test

  Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

• Change in cortical motor map volume

  Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

Study Arms (2)

Active tDCS

EXPERIMENTAL

Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity.

Device: transcranial direct current stimulation; Behavioral: Intensive upper extremity motor training

Sham tDCS

SHAM COMPARATOR

Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity.

Device: transcranial direct current stimulation; Behavioral: Intensive upper extremity motor training

Interventions

transcranial direct current stimulation DEVICE

This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Active tDCS; Sham tDCS

Intensive upper extremity motor training BEHAVIORAL

This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
• sustained injury at least 1 year prior to enrollment (i.e., chronic); and
• Men and women between the ages of 18-65.

You may not qualify if:

• history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
• cognitive deficits severe enough to preclude informed consent;
• positive pregnancy test or being of childbearing age and not using appropriate contraception;
• presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
• decubitus ulcers that might interfere with intervention;
• cardiac or neural pacemakers;
• fixed UE contractures;
• untreated depression;
• concurrent participation in occupational therapy;
• within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.

Sponsors & Collaborators

• Sara Shahid Salles: lead
• Wings for Life: collaborator

Study Sites (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Bronchiolitis Obliterans Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Sara Salles, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 17, 2019
• Study Start: July 1, 2019
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)