TRanscutaneous lImb reCovEry Post-Stroke (TRICEPS): study protocol for a randomised, controlled, multiarm, multistage...

Area of Science:

• Neuroscience
• Rehabilitation Medicine
• Clinical Trials

Background:

• Arm weakness is a major cause of disability post-stroke.
• Invasive vagus nerve stimulation (VNS) aids arm recovery, but its safety and efficacy are unknown for non-invasive transcutaneous VNS (tVNS).
• Understanding tVNS mechanisms is crucial for stroke rehabilitation.

Purpose of the Study:

• To determine the effectiveness of tVNS paired with rehabilitation for improving arm motor function in chronic stroke survivors.
• To explore the underlying mechanisms of action for tVNS in stroke recovery.

Main Methods:

• A UK multicentre, double-blinded, superiority, randomised controlled trial (TRICEPS) involving up to 243 participants.
• Participants receive either active or sham transcutaneous vagus nerve stimulation (tVNS) delivered via a movement-activated system during 12 weeks of repetitive task training.
• Primary outcome is the change in Upper Limb Fugl-Meyer score at 91 days; secondary outcomes include motor function, spasticity, and quality of life. A mechanistic substudy will use MRI and cytokine analysis.

Main Results:

• Participant recruitment commenced on November 30, 2023. (Note: As this is a protocol, results are not yet available).

Conclusions:

• The TRICEPS trial will provide critical data on the efficacy and mechanisms of tVNS for upper limb recovery in chronic stroke.
• Findings may lead to novel, non-invasive therapeutic strategies for post-stroke arm weakness.