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NCT Number: NCT04101695

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

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].

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Please Select, 13620, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes of concentration of deoxyhemoglobin

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

    detected by fNIRS and implies cortical metabolic changes

  2. Changes of concentration of oxyhemoglobin

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

    detected by fNIRS and implies cortical metabolic changes

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2019
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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