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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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);
  2. sustained injury at least 1 year prior to enrollment (i.e., chronic); and
  3. Men and women between the ages of 18-65.

Exclusion Criteria

  1. history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
  2. cognitive deficits severe enough to preclude informed consent;
  3. positive pregnancy test or being of childbearing age and not using appropriate contraception;
  4. 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;
  5. decubitus ulcers that might interfere with intervention;
  6. cardiac or neural pacemakers;
  7. fixed UE contractures;
  8. untreated depression;
  9. concurrent participation in occupational therapy;
  10. within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active tDCS
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
    This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
  • Behavioral: Intensive upper extremity motor training
    This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.
Sham Comparator
Sham tDCS
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
    This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
  • Behavioral: Intensive upper extremity motor training
    This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky 40504
Contact:
Elizabeth Powell, MS
859-323-6889
elizabeth.salmon@uky.edu

More Details

NCT ID
NCT03954496
Status
Recruiting
Sponsor
University of Kentucky

Study Contact

Elizabeth Powell, MS
(859) 323-6889
elizabeth.salmon@uky.edu

Detailed Description

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.