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

Hemodynamic Response of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Cerebellar Hemisphere in Healthy Subjects: A Pilot Trial

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].

Study Overview

• Status: Completed
• Conditions: Stroke; Transcranial Direct Current Stimulation; Functional Near Infrared Spectroscopy
• Intervention / Treatment: Device: tDCS

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Please Select
    • Seongnam-si, Please Select, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sham tDCS- washout period- anodal tDCS; 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; 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.
Active Comparator: anodal tDCS- washout period- sham tDCS; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Won-Seok Kim, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: B-1908-558-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to share the individual data publicly.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No