Improving Hand Recovery With Neuromodulation in Tetraplegia

NCT ID: NCT03954496

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-03-24

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.

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.

Conditions

Spinal Cord Injuries; Tetraplegia, Unspecified, Incomplete, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

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

Intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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

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.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

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

Intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wings for Life

OTHER

Sponsor Role: collaborator

Sara Shahid Salles

OTHER

Sponsor Role: lead

Responsible Party

Sara Shahid Salles

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sara Salles, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

201810171642

Identifier Type: -

Identifier Source: org_study_id