Clinical trial NCT06740591: HD-tDCS for Pain Reduction in Post-Stroke Pain: a Randomized Crossover Trial
Official title: Evaluation of the Efficacy and Safety of High-Definition Transcranial Direct Current Stimulation for Pain Reduction in Post-Stroke Pain Patients: Investigator-Initiated, Single-Center, Randomized, Crossover, Single-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Pain
CPSP
TDCS
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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.

Primary outcomes:
measure: Change of pain score in Brief Pain Inventory(BPI)
timeFrame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)
Secondary outcomes:
measure: Change of pain score in Neuropathic Pain Scale(NPS)
timeFrame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)
measure: Change of depression score in Beck Depression Inventory-II(BDI-II)
timeFrame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)
measure: Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)
timeFrame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)
measure: Change in Blood Pressure to Sustained Muscle Contraction
timeFrame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Young-Il Shin, Dr.
role: STUDY_DIRECTOR
References: