HD-tDCS for Pain Reduction in Post-Stroke Pain: a Randomized Crossover Trial

Pusan National University Yangsan Hospital

Status: Active, not recruiting

Conditions: Stroke; CPSP; TDCS; Pain

Treatments: Device: Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS); Device: HD-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06740591

23-2023-001

Details and patient eligibility

About

This study aims to assess the effectiveness of multichannel transcranial direct current stimulation (tDCS) in alleviating pain and to evaluate its safety in patients with central post-stroke pain (CPSP)

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Adults aged between 19 and 90 years.
• Diagnosed with first-ever stroke based on clinical observation and neuroimaging by a physician.
• Stroke lesion located in the cortex or subcortex [basal ganglia (BG) or thalamus].
• Fulfillment of mandatory criteria for pain (pain in the body part corresponding to central nervous system lesions, onset of pain immediately after stroke, confirmation that the pain corresponds to the lesion site, exclusion of other causes of pain such as peripheral neuropathic pain).
• Cognitive ability sufficient to understand and follow the instructions of the researcher.
• Voluntary consent to participate in the clinical trial and signed informed consent.

Exclusion Criteria :

• History of fractures or orthopedic surgeries on the affected side.
• Presence of significant pre-existing neurogenic disorders.
• Co-existing severe psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia.
• Complex regional pain syndrome (CRPS) diagnosed based on Budapest criteria.
• Other causes of pain in the affected area, such as peripheral nerve damage.
• Exclusion criteria for transcranial magnetic stimulation (e.g., pregnancy, cancer, patients with abnormal responses to stimulation, presence of intracranial metal implants, hypersensitivity to pain, history of seizures, or injuries/skin conditions at electrode attachment sites).
• Deemed unsuitable for participation in the study by the principal investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Experimental : HD-tDCS

Experimental group

Description:

The HD-tDCS stimulation was applied for 20 minutes, 5 times a week, over a total of 10 sessions.

Treatment:

Device: HD-tDCS

Sham HD-tDCS

Sham Comparator group

Description:

The Sham HD-tDCS stimulation was applied for 20 minutes, 5 times a week, over a total of 10 sessions.

Treatment:

Device: Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS)