Improving Hand Recovery With Neuromodulation in Tetraplegia (IGNITE)

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injuries; Tetraplegia, Unspecified, Incomplete, Chronic
• Intervention / Treatment: Device: transcranial direct current stimulation; Behavioral: Intensive upper extremity motor training

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • University of Kentucky at Cardinal Hill Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Semi-structured interview about study	Participants will be asked about motivations and goals for the study.	Baseline
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

Collaborators and Investigators

• Sponsor: Sara Shahid Salles
• Collaborators: Wings for Life
• Investigators: Principal Investigator: Sara Salles, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): March 24, 2020
• Study Completion (Actual): March 24, 2020

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; rehabilitation; activities of daily living; neuroplasticity; transcranial magnetic stimulation; motor training
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: 201810171642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No