BalancetDCSNCT06383039
Transcranial Direct Current Stimulation and Balance
A study testing Transcranial Direct Current Stimulation in people with Balance, run by Zeynep Soy at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2022to 13 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Being diagnosed with a psychological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transcranial Direct Current Stimulation on Balance on Supplementary Motor Area and Cerebellum in Healthy Individuals
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.
Read the detailed description
Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The cerebellum plays an important role in the planning, initiation and stability of movements, as well as in postural control and balance. The Supplementary Motor Area (SMA) is a section of the cortex that plays a major role in planning both simple and complex motor movements; It has many functions such as sequence of movements (turning one's hand before picking up an object), learning (learning a new balance task), acquiring grammar. The SMA is somatotopic organized and has direct reciprocal connections with the primary motor cortex (M1). Independent of the primary motor cortex (M1), the SMA is thought to play a crucial role in planning motor actions before movement begins. It also contributes to the planning of all body movements together with the basal ganglia and cerebellum during challenging balance tasks.
Modulation of neural regions underlying balance control may be a potential alternative for therapy. Transcranial direct current stimulation (tDCS) is a non-invasive and safe tool that can modulate cerebellar activity. tDCS is an easy, inexpensive and portable device to implement. There are 3 different types of stimulation. While anodal stimulation promotes neural excitability by causing subthreshold depolarization, cathodal stimulation inhibits neural activity, and in addition, anode-cathode application, in which two types of stimulation are used together, provides both facilitation and inhibition according to electrode placement. In a study conducted by Foerster et al. in healthy individuals in 2017, it was found that cerebellar tDCS increased balance stability, and in a study by Ehsani et al. in healthy individuals over 60 years of age in 2017, cerebellar tDCS increased the Berg Balance balance score. In a study conducted by Steiner et al. in 2016 in which cerebellar tDCS was applied to young individuals, it was observed that the trunk deviation angle during balance was decreased in men, while a similar study by Inukai et al. showed a decrease in oscillation after cathodal cerebellar tDCS.
There are studies showing that tDCS applied to the supplementary motor area has positive contributions to balance. It has been shown by Nomura et al. that tDCS applied to the supplementary motor area in healthy individuals causes a significant increase in balance.
There is no study comparing supplementary motor area and cerebellar area application in healthy individuals where tDCS is applied.
In line with these studies, 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.
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. Evaluations will be made at the beginning and will be repeated immediately after tDCS applications.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Being diagnosed with a psychological disorder.
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
It will be evaluated with IBM SPSS "Statistical Package for Social Sciences".
- Conditions
- Balance
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- tDCS, balance, supplementary motor area, cerebellum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Sham comparator | Sham transcranial Direct Current Stimulation Receives: Device: Transcranial Direct Current Stimulation |
| sma tDCS | Active comparator | Anodal-supplementary motor area transcranial Direct Current Stimulation Receives: Device: Transcranial Direct Current Stimulation |
| cerebellar tDCS | Active comparator | Anodal-cerebellar transcranial Direct Current Stimulation Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start16 May 2022
- Primary completion6 Sep 2022
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants received 3 different interventions at different times.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Soy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Soy, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383039
- Sponsor's protocol ID
- ZSoy
- Acronym
- tDCS
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28903772Hayduk-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.
PubMed 24064279Peterka RJ; New Collective Author. Sensorimotor integration in human postural control. J Neurophysiol. 2002 Sep;88(3):1097-118. doi: 10.1152/jn.2002.88.3.1097.
PubMed 12205132Hupfeld 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.
PubMed 27909747
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation on Balance on Supplementary Motor Area and Cerebellum in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06383039
- Acronym / sponsor ID
- tDCS / ZSoy
- Conditions
- Balance
- Keywords
- tDCS, balance, supplementary motor area, cerebellum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zeynep SoyUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The cerebellum plays an important role in the planning, initiation and stability of movements, as well as in postural control and balance. The Supplementary Motor Area (SMA) is a section of the cortex that plays a major role in planning both simple and complex motor movements; It has many functions such as sequence of movements (turning one's hand before picking up an object), learning (learning a new balance task), acquiring grammar. The SMA is somatotopic organized and has direct reciprocal connections with the primary motor cortex (M1). Independent of the primary motor cortex (M1), the SMA is thought to play a crucial role in planning motor actions before movement begins. It also contributes to the planning of all body movements together with the basal ganglia and cerebellum during challenging balance tasks.
Modulation of neural regions underlying balance control may be a potential alternative for therapy. Transcranial direct current stimulation (tDCS) is a non-invasive and safe tool that can modulate cerebellar activity. tDCS is an easy, inexpensive and portable device to implement. There are 3 different types of stimulation. While anodal stimulation promotes neural excitability by causing subthreshold depolarization, cathodal stimulation inhibits neural activity, and in addition, anode-cathode application, in which two types of stimulation are used together, provides both facilitation and inhibition according to electrode placement. In a study conducted by Foerster et al. in healthy individuals in 2017, it was found that cerebellar tDCS increased balance stability, and in a study by Ehsani et al. in healthy individuals over 60 years of age in 2017, cerebellar tDCS increased the Berg Balance balance score. In a study conducted by Steiner et al. in 2016 in which cerebellar tDCS was applied to young individuals, it was observed that the trunk deviation angle during balance was decreased in men, while a similar study by Inukai et al. showed a decrease in oscillation after cathodal cerebellar tDCS.
There are studies showing that tDCS applied to the supplementary motor area has positive contributions to balance. It has been shown by Nomura et al. that tDCS applied to the supplementary motor area in healthy individuals causes a significant increase in balance.
There is no study comparing supplementary motor area and cerebellar area application in healthy individuals where tDCS is applied.
In line with these studies, 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.
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. Evaluations will be made at the beginning and will be repeated immediately after tDCS applications.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Being diagnosed with a psychological disorder.
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
It will be evaluated with IBM SPSS "Statistical Package for Social Sciences".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All participants received 3 different interventions at different times.
| Arm | Type | Receives |
|---|---|---|
| sham tDCS | Sham comparator | Device: Transcranial Direct Current StimulationSham transcranial Direct Current Stimulation |
| sma tDCS | Active comparator | Device: Transcranial Direct Current StimulationAnodal-supplementary motor area transcranial Direct Current Stimulation |
| cerebellar tDCS | Active comparator | Device: Transcranial Direct Current StimulationAnodal-cerebellar transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Being diagnosed with a psychological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationEvaluations 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 | Device | cerebellar tDCS, sham tDCS, sma tDCS |
Primary outcome
Demographic Information Form
Time frame: 4 months
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
Wii-Fit
Time frame: 4 months
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.
balance error scoring system
Time frame: 4 months
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
star excursion balance test
Time frame: 4 months
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.
Time Up & Go Test
Time frame: 4 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 28903772Elsner 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.
- Background: PubMed 24064279Hayduk-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.
- Background: PubMed 12205132Peterka RJ; New Collective Author. Sensorimotor integration in human postural control. J Neurophysiol. 2002 Sep;88(3):1097-118. doi: 10.1152/jn.2002.88.3.1097.
- Background: PubMed 27909747Hupfeld 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Balance, run by Zeynep Soy at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06383039, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.