Improving Hand Recovery With Neuromodulation in Tetraplegia (IGNITE)

Sara Shahid Salles

Status: Terminated

Conditions: Spinal Cord Injuries; Tetraplegia, Unspecified, Incomplete, Chronic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03954496

201810171642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

Active tDCS

Experimental group

Description:

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.

Treatment:

Device: transcranial direct current stimulation

Behavioral: Intensive upper extremity motor training

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: transcranial direct current stimulation

Behavioral: Intensive upper extremity motor training