NCT05612165

Brief Summary

The purpose of this study is to verify the effectiveness and safety of transcranial direct current stimulation in patients with central post-stroke pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

November 3, 2022

Last Update Submit

August 4, 2024

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Change of pain score in Brief Pain Inventory(BPI)

    Brief Pain Inventory(BPI) is used for measurement. The Brief Pain Inventory (BPI) is a tool used to assess pain severity and its impact on daily functions. The BPI typically uses an 11-point numeric rating scale (NRS) for its pain severity and pain interference items. Each item is rated from 0 to 10. Pain Severity: 0 (no pain) to 10 (pain as bad as you can imagine). Pain Interference: 0 (does not interfere) to 10 (completely interferes).

    Baseline, after 2 weeks(after the end of intervention)

Secondary Outcomes (3)

  • Change of pain score in Neuropathic Pain Scale(NPS)

    Baseline, after 2 weeks(after the end of intervention)

  • Change of depression score in Beck Depression Inventory-II(BDI-II)

    Baseline, after 2 weeks(after the end of intervention)

  • Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)

    Baseline, after 2 weeks(after the end of intervention)

Study Arms (2)

tDCS group

EXPERIMENTAL
Device: Transcranial Direct Current Stimulation(tDCS)

Control group

SHAM COMPARATOR
Device: Sham Transcranial Direct Current Stimulation(sham tDCS)

Interventions

Transcranial Direct Current Stimulation(tDCS)DEVICE

The tDCS intervention was conducted for 20 minutes(2000μA) each time, 5 times a week for 2 weeks, a total of 10 times.

tDCS group
Sham Transcranial Direct Current Stimulation(sham tDCS)DEVICE

The sham tDCS intervention was conducted for 20 minutes(0μA) each time, 5 times a week for 2 weeks, a total of 10 times.

Control group

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 19 to 90 years old
  • Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis
  • A person whose stroke lesions are cortex or subcortex
  • A person who satisfies 'Mandatory criteria'
  • Those with cognitive ability to understand and follow the researcher's instructions
  • Those who voluntarily agree to participate in this clinical trial and signed the agreement

You may not qualify if:

  • Those who have a fracture or have undergone orthopedic surgery
  • In case of accompanying serious neurological diseases
  • In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
  • Those with complex part pain syndrome by Budapest Criteria
  • If there is a cause of other pain in the relevant area, such as peripheral nerve damage
  • If the researcher is judged to be judged that the participation in this study is not appropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

June 9, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations

KR(1)