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A Telerehabilitation Program for SCI

Primary Purpose

Incomplete Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring Cervical Spinal Cord Injury, upper limb, tDCS, telerehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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;
  2. upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;
  3. no brain injury;
  4. no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  5. no contradiction to tDCS;
  6. access to internet at home.

Exclusion Criteria:

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

Sites / Locations

  • The Institute for Rehabilitation and Research (TIRR) at Memorial HermannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population

Secondary Outcome Measures

Adherence with the therapy
Number of sessions attended
Adherence with the therapy
Number of drop-outs
Feasibility of home intervention
Participants perception in usefulness of intervention on a scale from 0-10. Higher numbers reflecting higher usability.
Grip Strength
Maximum force generated by hand muscles and measured with a hand-held dynamometer
Spinal Cord Injury Independence Measure (SCIM III)-Self Care
Assessment of achievements of self care, score ranges between 0 to 20 with higher numbers reflecting higher level of independence in daily functions
Incidence of adverse events
Collection of adverse events during the treatment period.

Full Information

First Posted
June 25, 2021
Last Updated
May 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Mission Connect a project of TIRR Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04977037
Brief Title
A Telerehabilitation Program for SCI
Official Title
Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Mission Connect a project of TIRR Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Spinal Cord Injury (SCI) has been associated with serious reduction in functional independence. Despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of SCI population are able to receive intensive in-clinic treatment. Difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. Currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. The literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore that CST activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (M1). However, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. To address these questions, 36 adults (above 18 years) with cervical SCI will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. The anodal tDCS will be applied over primary motor cortex (M1) at an intensity of 2mA for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. Primary outcome measure is change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) from baseline to immediately after treatment and 4-weeks follow-up. The session will be supervised in real-time via videoconferencing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury
Keywords
Cervical Spinal Cord Injury, upper limb, tDCS, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
active or sham tDCS
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Description
This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population
Time Frame
Change from baseline at 2 weeks and at 1 month
Secondary Outcome Measure Information:
Title
Adherence with the therapy
Description
Number of sessions attended
Time Frame
Treatment Day 1- Day 10
Title
Adherence with the therapy
Description
Number of drop-outs
Time Frame
Between enrollment and 1-month follow-up
Title
Feasibility of home intervention
Description
Participants perception in usefulness of intervention on a scale from 0-10. Higher numbers reflecting higher usability.
Time Frame
Change from baseline at 2 weeks and at 1 month
Title
Grip Strength
Description
Maximum force generated by hand muscles and measured with a hand-held dynamometer
Time Frame
Change from baseline at 2 weeks and at 1 month
Title
Spinal Cord Injury Independence Measure (SCIM III)-Self Care
Description
Assessment of achievements of self care, score ranges between 0 to 20 with higher numbers reflecting higher level of independence in daily functions
Time Frame
Change from baseline at 2 weeks and at 1 month
Title
Incidence of adverse events
Description
Collection of adverse events during the treatment period.
Time Frame
From treatment day1 to treatment day10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuray Yozbatiran, PhD, PT
Phone
7137975282
Email
Nuray.Yozbatiran@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Miller, BS
Phone
7137977132
Email
Alyssa.Miller@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuray Yozbatiran, PhD, PT
Organizational Affiliation
The University of Texas Health Sciences Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuray Yozbatiran, PhD, PT
Phone
713-797-5282
Email
Nuray.Yozbatiran@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Nedley
Phone
7137977132
Email
Kathryn.Nedley@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Xu Zhang, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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A Telerehabilitation Program for SCI

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