Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects

NCT04101695 | Completed

• 1 other identifier: B-1908-558-004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitation of activities of daily livings. Noninvasive neuromodulation is one of the therapies for motor recovery, which includes transcranial magnetic stimulation and transcranial direct current stimulation(tDCS). Anodal tDCS increases excitability and cathodal tDCS decreases excitability of neurons. In systematic reviews, tDCS applied over primary motor cortex showed positive results on motor learning and improvements of hand fine motors. Recently, there has been trials of tDCS over cerebellum, considering the connectivity of primary motor cortex and cerebellum in motor controls. However, the results of these trials are yet contradictory, and the study using the functional near infrared spectroscopy to prove the effects of tDCS over distant area is lacking. Therefore, in this study, we used functional near infrared spectroscopy (fNIRS) to observe the hemodynamic change of primary motor cortex when applying tDCS over cerebellum ascertain their connectivity. In this crossover design, participants are randomly allocated to "sham tDCS-washout period-anodal tDCS group" or "anodal tDCS- washout period- sham tDCS group". The recording of fNIRS starts 3 minutes before the tDCS stimulation and continues throughout 20 minutes of stimulation, until 30 minutes after the stimulation cessation. After 7 days of washout period, second recording is done as the same protocol. Outcome measures are the changes of concentration of deoxyhemoglobin \[deoxy-Hb\] and oxyhemoglobin \[oxy-Hb\].

Conditions

Stroke; Transcranial Direct Current Stimulation; Functional Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (2)

• Changes of concentration of deoxyhemoglobin

  detected by fNIRS and implies cortical metabolic changes

  comparison between sham and anodal tDCS (at least 7 days apart)

• Changes of concentration of oxyhemoglobin

  detected by fNIRS and implies cortical metabolic changes

  comparison between sham and anodal tDCS (at least 7 days apart)

Study Arms (2)

sham tDCS- washout period- anodal tDCS

ACTIVE COMPARATOR

Ybrain tDCS System (Ybrain, Korea) is used. Anode of tDCS is placed over right cerebellar hemisphere (3cm lateral from the occipital protuberance) and cathode over the on ipsilateral buccinator muscle. For Sham tDCS, total stimulation lasts 90 seconds: ramp up period of 30 seconds, stimultation for intensity of 2mA for 30 seconds, and ramp down period of 30 seconds. At least 7 days of washout period is in between two tDCS. For Anodal tDCS, 20 minutes of stimulation for intensity of 2mA.

Device: tDCS

anodal tDCS- washout period- sham tDCS

ACTIVE COMPARATOR

Ybrain tDCS System (Ybrain, Korea) is used. Anode of tDCS is placed over right cerebellar hemisphere (3cm lateral from the occipital protuberance) and cathode over the on ipsilateral buccinator muscle. For Anodal tDCS, 20 minutes of stimulation for intensity of 2mA. At least 7 days of washout period is in between two tDCS. For Sham tDCS, total stimulation lasts 90 seconds: ramp up period of 30 seconds, stimultation for intensity of 2mA for 30 seconds, and ramp down period of 30 seconds.

Device: tDCS

Interventions

tDCS DEVICE

Ybrain tDCS System (Ybrain, Korea) is used for anodal stimulation of cerebellar hemisphere. Anode of tDCS is placed over right cerebellar hemisphere (3cm lateral from the occipital protuberance) and cathode over the on right buccinator muscle.

anodal tDCS- washout period- sham tDCS; sham tDCS- washout period- anodal tDCS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 19 years or older
• No known brain disorders

You may not qualify if:

• Uncontrolled or unstalbe medical condition
• Pregnant
• Scalp problem which interferese with tDCS
• metals in the head (example: clip, coil), cochlear implants

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Please Select, 13620, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

• Won-Seok Kim, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 24, 2019
• Study Start: September 9, 2019
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)