A Telerehabilitation Program for SCI

NCT04977037 | Completed Results FDA Device

• 1 other identifier: HSC-MS-21-0114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).

Conditions

Incomplete Spinal Cord Injury

Keywords

Cervical Spinal Cord Injury; upper limb; tDCS; telerehabilitation

Outcome Measures

Primary Outcomes (3)

• Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

  The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.

  Baseline

• Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

  The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.

  2 weeks

• Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

  The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.

  6 weeks

Secondary Outcomes (12)

• Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended

  Treatment Day 1- Day 10

• Adherence With the Therapy as Assessed by the Number of Participant Drop-outs

  Between enrollment and 6 weeks

• Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS)

  Day 10

• Grip Strength

  Baseline

• Grip Strength

  2 weeks

Study Arms (2)

Active tDCS

EXPERIMENTAL

Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes

Device: Sham tDCS

Interventions

Active tDCS DEVICE

Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.

Active tDCS

Sham tDCS DEVICE

Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of a chronic incomplete cervical lesion as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months post-injury;
• upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;
• no brain injury;
• no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
• no contradiction to tDCS;
• access to internet at home.

You may not qualify if:

• prior history of seizure;
• chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants);
• any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score ≥ than 3 out of 4.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Mission Connect a project of TIRR Foundation: collaborator

Study Sites (1)

The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Nuray Yozbatiran, PhD, PT
• Organization: The University of Texas Health Sciences Center at Houston

Nuray.Yozbatiran@uth.tmc.edu

7137975282

Study Officials

• Nuray Yozbatiran, PhD, PT

  The University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: active or sham tDCS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blind, randomized controlled trial

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 26, 2021
• Study Start: July 1, 2021
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)