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A Telerehabilitation Program for SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04977037
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : May 10, 2023
Sponsor:
Collaborator:
Mission Connect a project of TIRR Foundation
Information provided by (Responsible Party):
Nuray Yozbatiran, The University of Texas Health Science Center, Houston

Study Description
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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).

Condition or disease Intervention/treatment Phase
Incomplete Spinal Cord Injury Device: Active tDCS Device: Sham tDCS Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: active or sham tDCS
Primary Purpose: Treatment
Official Title: Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active tDCS
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
 Device: Active tDCS
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 Comparator: Sham tDCS
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
 Device: Sham tDCS
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.


Outcome Measures
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Primary Outcome Measures :
  1. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    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 :
  1. Adherence with the therapy [ Time Frame: Treatment Day 1- Day 10 ]
    Number of sessions attended

  2. Adherence with the therapy [ Time Frame: Between enrollment and 1-month follow-up ]
    Number of drop-outs

  3. Feasibility of home intervention [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Participants perception in usefulness of intervention on a scale from 0-10. Higher numbers reflecting higher usability.

  4. Grip Strength [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Maximum force generated by hand muscles and measured with a hand-held dynamometer

  5. Spinal Cord Injury Independence Measure (SCIM III)-Self Care [ Time Frame: Change from baseline at 2 weeks and at 1 month ]
    Assessment of achievements of self care, score ranges between 0 to 20 with higher numbers reflecting higher level of independence in daily functions

  6. Incidence of adverse events [ Time Frame: From treatment day1 to treatment day10 ]
    Collection of adverse events during the treatment period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977037


Contacts
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Contact: Nuray Yozbatiran, PhD, PT 7137975282 Nuray.Yozbatiran@uth.tmc.edu
Contact: Alyssa Miller, BS 7137977132 Alyssa.Miller@uth.tmc.edu

Locations
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United States, Texas
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Nuray Yozbatiran, PhD, PT    713-797-5282    Nuray.Yozbatiran@uth.tmc.edu   
Contact: Kathryn Nedley    7137977132    Kathryn.Nedley@uth.tmc.edu   
Sub-Investigator: Xu Zhang, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Mission Connect a project of TIRR Foundation
Investigators
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Principal Investigator: Nuray Yozbatiran, PhD, PT The University of Texas Health Sciences Center at Houston
More Information
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Responsible Party: Nuray Yozbatiran, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04977037    
Other Study ID Numbers: HSC-MS-21-0114
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nuray Yozbatiran, The University of Texas Health Science Center, Houston:
Cervical Spinal Cord Injury
upper limb
tDCS
telerehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System