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

Spinal Cord, 2022 · DOI: https://doi.org/10.1038/s41393-022-00768-z · Published: March 5, 2022

Spinal Cord Injury Neurology Rehabilitation

Simple Explanation

This study investigates whether transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, can improve upper extremity function when combined with rehabilitation in individuals with tetraplegia due to chronic spinal cord injury. The trial involves applying weak electrical currents to the brain to enhance the excitability of residual motor pathways, potentially leading to improved strength and dexterity. Participants will undergo 15 sessions of either real or sham tDCS combined with upper extremity rehabilitation, and their motor skills, functional abilities, and independence will be assessed.

Study Duration

3–5 weeks intervention, 3-month follow-up

Participants

44 adults with tetraplegia, 20 able-bodied controls

Evidence Level

Level I/II, Multisite randomized, controlled, double-blinded phase I/II clinical trial

Key Findings

1
The primary outcome measure is upper extremity motor impairment assessed using the Graded Redeﬁned Assessment of Strength, Sensibility and Prehension (GRASSP) scale.
2
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).
3
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.

Research Summary

This multisite clinical trial aims to evaluate the safety, feasibility, and efficacy of combining tDCS with rehabilitation to improve upper extremity function in individuals with chronic cervical SCI. The study will assess motor impairment, functional abilities, independence, and participation restrictions using various standardized measures. Neurophysiological changes, safety, and feasibility will also be examined using TMS and adverse event reports.

Practical Implications

Rehabilitation Strategies

The study could refine rehabilitation strategies for individuals with tetraplegia by integrating non-invasive brain stimulation techniques.

Clinical Practice

If proven effective, tDCS combined with rehabilitation could become a standard clinical practice to improve upper extremity function and independence.

Future Research

The findings will inform future research on neuromodulation and rehabilitation for spinal cord injury.

Study Limitations

1
The study relies on a specific protocol of tDCS and rehabilitation, which may not be generalizable to all settings.
2
Participant inclusion criteria, such as muscle strength imbalance, may limit the applicability of the results to all individuals with tetraplegia.
3
The study's sample size of 44 participants may not be sufficient to detect small but clinically meaningful effects.

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