Improving Hand Recovery With Neuromodulation in Tetraplegia

Spinal Cord Injuries Clinical Trial

— IGNITE  

Official title:

Improving Hand Recovery With Neuromodulation in Tetraplegia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03954496
• Other study ID #: 201810171642
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: March 24, 2020

Study information

• Verified date: June 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 24, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia, Unspecified, Incomplete, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky at Cardinal Hill Rehabilitation Hospital	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Sara Shahid Salles	Wings for Life

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Medical Research Council Scale Upper Extremity Manual Muscle Test	This evaluates the strength of various muscles in the upper extremity. Each muscle that is tested can be scored from a minimum of 0, indicating no strength, up to a maximum of 5, indicating normal strength. Scores are assigned to each side by summing the scores from each of the 41 individual muscles, with a minimum possible total score of 0 and a maximum possible total score of 205. Higher values indicate greater strength.	Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Secondary	Change in Canadian Occupational Performance Measure	The participant selects 5 tasks they would like to be able to perform, and score their performance as well as satisfaction with their performance of the tasks.	Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Secondary	Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension	This measures strength, sensibility, and prehension to obtain information about motor and sensory function.	Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Secondary	Change in Van Lieshout Test	This test evaluates upper extremity motor performance in cervical spinal cord injury.	Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Secondary	Change in cortical motor map volume	This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.	Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Secondary	Semi-structured interview about study	Participants will be asked about motivations and goals for the study.	Baseline
Secondary	Semi-structured interview about study	Participants will be asked about their experience in the study, whether they experienced any changes in function during the study, and whether they have recommendations for change.	Immediately post-intervention, 4-month follow-up