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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04101695
Other study ID # B-1908-558-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2019
Est. completion date April 7, 2021

Study information

Verified date August 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date April 7, 2021
Est. primary completion date April 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Functional Near Infrared Spectroscopy
  • Stroke
  • Transcranial Direct Current Stimulation

Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Please Select

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of concentration of deoxyhemoglobin detected by fNIRS and implies cortical metabolic changes comparison between sham and anodal tDCS (at least 7 days apart)
Primary Changes of concentration of oxyhemoglobin detected by fNIRS and implies cortical metabolic changes comparison between sham and anodal tDCS (at least 7 days apart)
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