Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

NCT04938076 | Completed

• 1 other identifier: OC19DESI0124
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (6)

• Fugl-Meyer (FM) motor scale, short form

  The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).

  at admission

• Fugl-Meyer (FM) motor scale, short form

  The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).

  at 7 days

• Fugl-Meyer (FM) motor scale, short form

  The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).

  at 3 month

• NIHSS (National Institutes of Health Stroke Scale)

  National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).

  at admission

• NIHSS (National Institutes of Health Stroke Scale)

  National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).

  at 7 days

• NIHSS (National Institutes of Health Stroke Scale)

  National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).

  at 3 month

Secondary Outcomes (1)

• modified Rankin scale

  at 3 month

Study Arms (2)

tDCS group

EXPERIMENTAL

tDCS stimulation * affected side : 1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2. 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) * contralateral unaffected side 1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2. 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)

Device: Transcranial direct current stimulation

Sham group

SHAM COMPARATOR

. Sham stimulation 1\) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation

Device: sham control

Interventions

Transcranial direct current stimulation DEVICE

Transcranial direct current stimulation on motor cortex

tDCS group

sham control DEVICE

sham control

Sham group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ischemic stroke patients within 2 days stroke onset
• of age
• corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)

You may not qualify if:

• pre-stroke disability (defined as modified Rankin Scale (mRS) \>=2)
• Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
• history of epilepsy
• advanced systemic disease or coexisting neurological/psychiatric disease
• severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead
• The Catholic University of Korea: collaborator

Study Sites (1)

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, 21431, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Taewon Kim, MD, PhD

  Incheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded randomized control trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD, PhD

Model Details: Double blinded randomized control trial

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 24, 2021
• Study Start: April 16, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)