Clinical trial NCT03954496: Improving Hand Recovery With Neuromodulation in Tetraplegia
Official title: Improving Hand Recovery With Neuromodulation in Tetraplegia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Tetraplegia, Unspecified, Incomplete, Chronic
Keywords: neuroplasticity
rehabilitation
transcranial direct current stimulation
transcranial magnetic stimulation
activities of daily living
motor training
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Wings for Life
First posted: 2019-05-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Spinal Cord Independence Measure
timeFrame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Secondary outcomes:
measure: Change in Medical Research Council Scale Upper Extremity Manual Muscle Test
timeFrame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
measure: Change in Canadian Occupational Performance Measure
timeFrame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
measure: Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension
timeFrame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
measure: Change in Van Lieshout Test
timeFrame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
measure: Change in cortical motor map volume
timeFrame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
measure: Semi-structured interview about study
timeFrame: Baseline
measure: Semi-structured interview about study
timeFrame: Immediately post-intervention, 4-month follow-up
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky at Cardinal Hill Rehabilitation Hospital
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Sara Salles, MD
role: PRINCIPAL_INVESTIGATOR
References: