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Improving Hand Recovery With Neuromodulation in Tetraplegia (IGNITE)

Primary Purpose

Spinal Cord Injuries, Tetraplegia, Unspecified, Incomplete, Chronic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

transcranial direct current stimulation

Intensive upper extremity motor training

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring neuroplasticity, rehabilitation, transcranial direct current stimulation, transcranial magnetic stimulation, activities of daily living, motor training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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);
sustained injury at least 1 year prior to enrollment (i.e., chronic); and
Men and women between the ages of 18-65.

Exclusion Criteria:

history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
cognitive deficits severe enough to preclude informed consent;
positive pregnancy test or being of childbearing age and not using appropriate contraception;
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;
decubitus ulcers that might interfere with intervention;
cardiac or neural pacemakers;
fixed UE contractures;
untreated depression;
concurrent participation in occupational therapy;
within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.

Sites / Locations

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Spinal Cord Independence Measure

This evaluates self-care, respiration and sphincter management, and mobility.

Secondary Outcome Measures

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 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 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 in Van Lieshout Test

This test evaluates upper extremity motor performance in cervical spinal cord injury.

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.

Semi-structured interview about study

Participants will be asked about motivations and goals for the study.

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.

Full Information

NCT ID

NCT03954496

First Posted

May 14, 2019

Last Updated

June 18, 2021

Sponsor

Sara Shahid Salles

Collaborators

Wings for Life

1. Study Identification

Unique Protocol Identification Number

NCT03954496

Brief Title

Improving Hand Recovery With Neuromodulation in Tetraplegia

Acronym

IGNITE

Official Title

Improving Hand Recovery With Neuromodulation in Tetraplegia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

Insufficient study staff

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

March 24, 2020 (Actual)

Study Completion Date

March 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sara Shahid Salles

Collaborators

Wings for Life

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Tetraplegia, Unspecified, Incomplete, Chronic

Keywords

neuroplasticity, rehabilitation, transcranial direct current stimulation, transcranial magnetic stimulation, activities of daily living, motor training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Experimental

Arm 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.

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Intensive upper extremity motor training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Spinal Cord Independence Measure

Description

This evaluates self-care, respiration and sphincter management, and mobility.

Time Frame