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Safety and efficacy of transcranial direct current stimulation in upper extremity rehabilitation after tetraplegia: protocol of a multicenter randomized, clinical trial. | LitMetric

AI Article Synopsis

  • A multisite, double-blinded clinical trial aims to assess the safety and effectiveness of noninvasive transcranial direct current stimulation (tDCS) combined with rehabilitation for improving upper extremity recovery in individuals with chronic cervical spinal cord injury (SCI).
  • The study involves 44 adults with tetraplegia, who will be randomly assigned to receive either active or sham tDCS alongside rehabilitation, with evaluations occurring at multiple points throughout the trial.
  • Primary outcome measures will focus on upper extremity motor impairment and functional abilities, while secondary measures will investigate changes in brain activity and track treatment feasibility and safety.

Article Abstract

Study Design: A multisite, randomized, controlled, double-blinded phase I/II clinical trial.

Objective: The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) with rehabilitation to promote paretic upper extremity recovery and functional independence in persons living with chronic cervical spinal cord injury (SCI).

Setting: Four-site trial conducted across Cleveland Clinic, Louis Stokes Veterans Affairs Medical Center of Cleveland and MetroHealth Rehabilitation Rehabilitation Institute of Ohio, and Kessler Foundation of New Jersey.

Methods: Forty-four adults (age ≥18 years) with tetraplegia following cervical SCI that occurred ≥1-year ago will participate. Participants will be randomly assigned to receive anodal tDCS or sham tDCS given in combination with upper extremity rehabilitation for 15 sessions each over 3-5 weeks. Assessments will be made twice at baseline separated by at least a 3-week interval, once at end-of-intervention, and once at 3-month follow-up.

Primary Outcome Measure(s): Primary outcome measure is upper extremity motor impairment assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scale. Functional abilities will be assessed using Capabilities of Upper Extremity-Test (CUE-T), while functional independence and participation restrictions will be evaluated using the self-care domain of Spinal Cord Independent Measure (SCIM), and Canadian Occupational Performance Measure (COPM).

Secondary Outcome Measures: Treatment-associated change in corticospinal excitability and output will also be studied using transcranial magnetic stimulation (TMS) and safety (reports of adverse events) and feasibility (attrition, adherence etc.) will also be evaluated.

Trial Registration: ClincalTrials.gov identifier NCT03892746. This clinical trial is being performed at four sites within the United States: Cleveland Clinic (lead site), Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) and MetroHealth Rehabilitation Institute in Ohio, and Kessler Foundation in New Jersey. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8896974PMC
http://dx.doi.org/10.1038/s41393-022-00768-zDOI Listing

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