NCT06383039

Brief Summary

Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

February 2, 2024

Last Update Submit

April 22, 2024

Conditions

Keywords

tDCSbalancesupplementary motor areacerebellum

Outcome Measures

Primary Outcomes (5)

  • Demographic Information Form

    Demographic Information Form includes the patient's personal information, sociodemographic and physical characteristics.İt includes: name, surname, date of the birth, using cigarette / alcohol, presence presence of disease, using drugs

    4 months

  • Wii-Fit

    Nintendo Wii Fit Balance Evaluation was carried out in a darkened room with no light. In this setup, the Nintendo Wii Fit image was projected on the wall with a projector. The patient's birth year and height were recorded according to the device's instructions. The patient's weight was calculated in centimeter by the device. The patient was taught how to step on the board. First, the patient was asked to stand looking straight ahead without moving, and the center of gravity on the right and left foot was calculated as a percentage. Then the patient's body mass index was calculated in kg/m\^2. Afterwards, the patient was asked to step in the middle of the balance board with one foot and maintain this position for 30 seconds. A single-leg stabilization test was performed separately for both feet and the results were recorded as a percentage.

    4 months

  • balance error scoring system

    2 different surfaces and 3 stance positions . Normal floor is used for flat surface, foam block is used for foam surface. Subjects apply the 6 conditions of the test in the following order: flat surface with two legs support, one foot support and tandem stance position; sponge surface with two legs support, one foot support and tandem stance. The duration of each position was measured by a smart watch for approximately 20 seconds. Each mistake made by individuals within 20 seconds was recorded as 1 point. Six different situations counted as errors are as follows: - Pulling the arms over the iliac crest - Opening the eyes - Taking a step, stumbling or falling - Flexing or abducting the hip joint more than 30° - Lifting the foot or heel off the ground - More than five seconds out of the test position staying too long. Error scores were calculated separately for each position and the total error score was obtained by adding the scores. Higher score indicates worse balance

    4 months

  • star excursion balance test

    On the determined floor, 4 strips cut in 2 meters length are adhered to form 45 degree angles between them. The participant waits in the middle of the star shape (the point where the lines intersect).The participant reaches as far as she can reach with her foot.Then the other line is passed and a total of 8 lines are completed in this way.At the end of each distance, a mark was made with a pencil so that you could measure it later. Highest score was obtained from 3 reaches in each direction.

    4 months

  • Time Up & Go Test

    3 meters area is determined in front of the chair. The patient is asked to get up from his seat and go to the designated place and sit down again. The time is recorded in seconds. shorter time indicates better balance

    4 months

Study Arms (3)

sham tDCS

SHAM COMPARATOR

Sham transcranial Direct Current Stimulation

Device: Transcranial Direct Current Stimulation

sma tDCS

ACTIVE COMPARATOR

Anodal-supplementary motor area transcranial Direct Current Stimulation

Device: Transcranial Direct Current Stimulation

cerebellar tDCS

ACTIVE COMPARATOR

Anodal-cerebellar transcranial Direct Current Stimulation

Device: Transcranial Direct Current Stimulation

Interventions

Evaluations will be made in the presence of a physiotherapist. Individuals; For demographic information • Demographic Information Form For Static Balance Evaluation: * Wii-Fit * Balance Error Scoring System For Dynamic Balance Assessment: * Star Balance Test * Timed Get Up and Go Test

cerebellar tDCSsham tDCSsma tDCS

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No neurological, sensory, motor, visual or cognitive impairment,
  • Volunteering to participate in the study,
  • Being between the ages of 18-25,
  • To have formal education at the university.

You may not qualify if:

  • Being diagnosed with a psychological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Location

Related Publications (4)

  • Elsner B, Kwakkel G, Kugler J, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving capacity in activities and arm function after stroke: a network meta-analysis of randomised controlled trials. J Neuroeng Rehabil. 2017 Sep 13;14(1):95. doi: 10.1186/s12984-017-0301-7.

    PMID: 28903772BACKGROUND
  • Hayduk-Costa G, Drummond NM, Carlsen AN. Anodal tDCS over SMA decreases the probability of withholding an anticipated action. Behav Brain Res. 2013 Nov 15;257:208-14. doi: 10.1016/j.bbr.2013.09.030. Epub 2013 Sep 21.

    PMID: 24064279BACKGROUND
  • Peterka RJ. Sensorimotor integration in human postural control. J Neurophysiol. 2002 Sep;88(3):1097-118. doi: 10.1152/jn.2002.88.3.1097.

    PMID: 12205132BACKGROUND
  • Hupfeld KE, Ketcham CJ, Schneider HD. Transcranial direct current stimulation (tDCS) to the supplementary motor area (SMA) influences performance on motor tasks. Exp Brain Res. 2017 Mar;235(3):851-859. doi: 10.1007/s00221-016-4848-5. Epub 2016 Dec 1.

    PMID: 27909747BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not informed which type of current was applied.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: All participants received 3 different interventions at different times.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2024

First Posted

April 25, 2024

Study Start

May 16, 2022

Primary Completion

September 6, 2022

Study Completion

May 13, 2023

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations