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

NCT ID: NCT06740591

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2025-07-30

Brief Summary

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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)

Detailed Description

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Conditions

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Stroke Pain CPSP TDCS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental : HD-tDCS

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

Group Type EXPERIMENTAL

HD-tDCS

Intervention Type DEVICE

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

Sham HD-tDCS

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

Group Type SHAM_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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HD-tDCS

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Eligibility Criteria

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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.
* Deemed unsuitable for participation in the study by the principal investigator.
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong-il Shin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Il Shin, Dr.

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Locations

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Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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23-2023-001

Identifier Type: -

Identifier Source: org_study_id