Effects of repetitive somatosensory stimulation on somatosensory deficits in patients with acute stroke

UMIN ID: UMIN000056301

Registered date:01/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with acute stroke
• Date of first enrollment: 2024/06/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Peripheral nerve somatosensory stimulation group 3 cm2 (1.5 x 2.0 cm) surface electrode is used as the stimulating electrode, and the peripheral nerves in the carpal region (median nerve and ulnar nerve) are stimulated. Electrical stimulation of both peripheral nerves is synchronized for simultaneous stimulation. Pulsed current is used for electrical stimulation, and the pulse width is 1 ms. Stimulation intensity is set at 90% of the motor threshold (the intensity at which weak contraction of the attached peripheral nerve-governing muscle is obtained), and the stimulation frequency is 20 Hz. The stimulation cycle is 2 seconds on/4 seconds off, and the stimulation duration is 20 minutes.
Sham Stimulation Group In the sham stimulation group, electrodes are applied as in the peripheral sensory stimulation group, but no peripheral sensory stimulation is performed, and the subjects are placed in a sitting position for 20 minutes. The subjects are verbally informed that the sham stimulation is a peripheral sensory stimulation intervention of imperceptible intensity.

Outcome(s)

• Primary Outcome: Somatosensory evoked potentials
• Secondary Outcome: Tactile threshold Vibration threshold Two-point discrimination threshold Fugl-meyer assessment Action research arm test Box and Block test 9-hole peg test Grip strength Functional independence measure (FIM)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: Patients who fall under any one of the following categories are excluded from the study. (1) Patients who have a pacemaker or other stimulating device in their body. (2) Patients with acute symptom changes such as worsening motor or sensory paralysis. (3) Patients who are unable to follow the examiner's instructions due to decreased level of consciousness or dementia (patients with an HDS-R score of 20 or less are excluded). (4) Patients with a history of epilepsy (5) Pregnant, lactating, possibly pregnant, or wishing to become pregnant during the study period. (6) Those who are unable to perform the evaluation.

Related Information

• Primary Sponsor: University of Fukui hospital
• Source(s) of Monetary Support: Japan Science and Technology Agency