The Long-term Simultaneous Motor Cortex Stimulation and Balance Training

NCT05983601 | Unknown DMC

• 2 other identifiers: 2021.404.IRB.119321S329
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial direct current stimulation (tDCS) is a simple, portable, and low-cost technology applied in neuroscience for therapeutic purposes and neurophysiological research of brain activity. Enhancing the impacts of training and improving performance in athletes through the use of tDCS is a significant aim for today. The primary purpose of this study is to determine how non-professional active athletes' balance and movement measurements can be affected by the simultaneous application of a 4-week balance training and anodal tDCS of motor cortex(M1). This study hypothesizes that anodal stimulation of motor cortex will enhance performance in balance training among moderately active and healthy participants. The study outcomes will provide data for literatures on performance enhancement by demonstrating how effective skill development can be acquired in a short time among moderately active athletes. In addition, the study outcomes will provide convenient tDCS parameter for future neuromodulation studies interested in the treatment of balance disorders in patients and the elderly. Uniquely, in our study, the link between tDCS and movement parameters will be investigated. Additionally, a long-term balance training program in combination with tDCS of M1 in amateur has never been tested in amateur athletes. The secondary purpose of the study is to obtain feedback from participants via pre- and post-tDCS and balance training, using continuous performance tests, estimated reaction time, and depression-anxiety scales to gather data on reaction time, anticipation, impulsivity, attention, and mood changes that directly affect athlete performance. In continuous performance test, a decrease in reaction times without an increase in the number of errors (misstep-commission) and the number of non-pressing (non-pressing-omission) will be considered as a successful outcome. While increasing balance performance and reducing the reaction time is anticipated as a positive outcome, simultaneously changes in mood, attention, and error rate is an unanticipated and undesired outcome. Although the selected stimulation area is not directly related to these functions, this study will additionally control for any potential changes that might have been missed in functions that are not the study's primary focus.

Conditions

Coordination and Balance Disturbances

Keywords

Balance training; Transcranial Direct Current Stimulation; Neuromodulation; Non-invasive brain stimulation

Outcome Measures

Primary Outcomes (3)

• Changes from Baseline in Dynamic Balance and Lower Extremity Functionality in Y-Balance Test Following 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per week.

  The Y-balance test measures dynamic balance and the functionality of lower extremity. Participants perform reach tasks in 3 different directions with their legs and the maximum length reached is recorded before and after the tDCS treatment with simultaneous balance training. Scores are calculated by taking the sum of reach direction lengths, dividing by the length of upper extremity and multiplying by 100 Change = (Week 4 Score - Baseline Score)

  Baseline and Week 4

• Changes from Baseline in BESS Scores Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week

  The Balance Error Scoring System is a standardized assessment tool that measures static balance and postural stability. In BESS, the number of errors or deviation from the normal stance is recorded, and changes in error are compared before and after tDCS treatment with simultaneous balance training. Change = (Week 4 Score - Baseline Score)

  Baseline and Week 4

• Changes from Baseline in Movement Parameters Recorded by Noraxon Myomotion 5 IMU Sensors During the Y-Balance test and BESS Movements Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week

  Noraxon Myomotion 5 IMU Sensors provide a detailed analysis of kinematics by quantifying motion and movement measures in various areas. These measures will be taken while participants perform Y-Balance and BESS movements. Change from baseline in Noraxon Myomotion 5 IMU Sensors parameters will allow for the interpretation of changes in precise movements performed in these tasks. Change = (Week 4 Score - Baseline Score)

  Baseline and Week 4

Secondary Outcomes (1)

• Changes from Baseline in Sustained Attention Measured by Continuous Performance Test Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week

  Baseline and Week 4

Study Arms (2)

Active tDCS+Balance training

ACTIVE COMPARATOR

The current intensity will be 2mA and the duration of stimulation will be 20 minutes with direct current stimulation. In the beginning and end of the tDCS stimulation, there will be 30 second ascent and descent period.

Device: Transcranial Direct Current Stimulation

Sham tDCS+Balance Training

SHAM COMPARATOR

In sham stimulation, the current will increase to 2 mA in the first thirty second, following by 30 second active stimulation, then it will be dropped to 0 mA. Brief electric current will be given in order to create a tingling sensation under electrodes.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

The anode electrode will be placed at the midline of the Cz according to international 10-20 EEG system, and the cathode electrode will be placed at the midline of forehead. In this way, both hemisphere of motor cortex can be stimulated which is used as protocol in various balance studies (Siedel-Marzi and Ragert, 2020b; Saruco et al., 2017). Participants will continue their training with tDCS (2mA) for 20 minutes. This application will continue three times a week for four weeks. In the end of the study, participants will be asked to guess which group they were in (active or sham).

Active tDCS+Balance training; Sham tDCS+Balance Training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Scoring below 19 on the Beck Depression Inventory
• Scoring 15 or below on the Beck Anxiety Scale
• Having no neurological, psychiatric, orthopedic, or inner ear-related diseases
• Not being a professional athlete in a branch involving balance training (e.g., gymnastics)
• Not using medication affecting the central nervous system
• Having not consumed alcohol at least 24 hours prior to the tests
• Having no metal implants or hip/knee prosthesis
• Not being pregnant

You may not qualify if:

• Scoring 19 or higher on the Beck Depression Inventory
• Scoring higher than 15 on Beck Anxiety Scale
• Being a professional athlete
• Using mediation affecting the central nervous system
• Alcohol consumption less than 24 hours prior to the test
• Having metal implants or hip/knee prosthesis
• Being pregnant

Sponsors & Collaborators

• Koc University Hospital: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• Marmara University: collaborator
• İstinye University: collaborator

Study Sites (1)

Koç University Hospital

Istanbul, 35310, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ezgi Tuna Erdoğan

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezgi Tuna Erdoğan

CONTACT

+90 533 643 47 49; ezerdogan@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ezgi Tuna Erdoğan

Model Details: Parallel controlled randomized double blind study

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: September 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: September 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)