Repetitive transcranial magnetic stimulation of the primary motor cortex improves movement performance by regulating neural oscillations
| ISRCTN | ISRCTN12867198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12867198 |
- Submission date
- 07/10/2024
- Registration date
- 11/10/2024
- Last edited
- 10/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Transcranial magnetic stimulation (TMS) could improve motor cortical excitability and balance dysfunction. However, the underlying neurophysiological mechanism of repetitive TMS (rTMS) combined with task-related brain state (TCBS) intervention remains unclear. This study investigates which brain oscillatory activities in which brain regions are involved in the TCBS intervention.
Who can participate?
Healthy adult volunteers aged between 20 and 75 years old
What does the study involve?
To investigate the neurophysiological mechanisms, rTMS will be applied to the motor cortex of subjects during movement tasks. Multichannel electroencephalography (EEG) signals in various frequency bands (θ, α, β, γ) will be obtained before, during, and after the intervention. The phase-locking value, conventional entropy, and coupling entropy will be introduced to investigate cross-frequency coupling characteristics (CFCC), within-frequency dynamic characteristics (WFDC), and cross-frequency coupling dynamic characteristics (CFCDC) respectively.
What are the possible benefits and risks of participating?
The study aims to quantify TMS-induced coupling and differences in dynamic characteristics and objectively evaluate the effects of TCBS. These calculations are significant for understanding the coupling characteristics and neurodynamic characteristics after TCBS modulation, potentially guiding the TCBS treatment of movement-related diseases.
The risk of rTMS in inducing a seizure is low ranging from 1/100,000 to 33/100,000, even in patient populations taking drugs acting on the central nervous system, at least with the use of traditional stimulation parameters and focal coils for which large data sets are available. While this is reassuring and helpful information for subjects, it remains necessary to be prepared to deal with a seizure that might arise in any experimental protocol.
Where is the study run from?
Key Laboratory of Intelligent Rehabilitation and Neuromodulation of Hebei Province, Yanshan University, China
When is the study starting and how long is it expected to run for?
September 2021 to August 2023
Who is funding the study?
1. National Key Research and Development Program of China
2. National Natural Science Foundation of China
3. Outstanding Youth of Hebei Natural Science Foundation
4. Hebei Key Research and Development Program
5. Hebei Province of Introduction of Overseas Talent
6. Central Government Guides Local Projects
7. Hebei Innovation Capability Improvement Plan Project
Who is the main contact?
Dr Lingdi Fu, ldfu@ysu.edu.cn
Contact information
Public, Scientific, Principal Investigator
No.438 Hebei Street West Section
Qinhuangdao City, Hebei Province
066000
China
 ORCID ID |
0000-0002-6608-7124 |
|---|---|
| Phone | +86 15022071790 |
| lingdifu123@126.com |
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details below to request participantt information sheet |
| Scientific title | TMPRNO: rTMS of M1 improves movement performance by regulating neural oscillations |
| Study acronym | TMPRNO |
| Study objectives | The present study aims to explore the regulator mechanism and look for potential biomarkers of repetitive transracial magnetic stimulation (TMS) intervention when combined with movement-related brain state. |
| Ethics approval(s) |
Approved 03/03/2022, First Hospital of Qinhuangdao Research Ethics Committee (The First Hospital of Qinhuangdao, 258 Wenhua Road, Qinhuangdao, 066005, China; +86-18830466169; 895638791@qq.com), ref: 2022A107 |
| Health condition(s) or problem(s) studied | Improve motor cortical excitability and balance dysfunction to provide practical guidance for the task-related brain state (TCBS) treatment of movement-related diseases, such as stroke |
| Intervention | Electroencephalography (EEG) signals were collected from 32 Ag-AgCl scalp electrodes located according to the International 10-10 system using a BrainAmp system (Brain Products, Gilching, Germany). The experimental sessions began with a resting state with eyes open (pre-REST), followed by task familiarization and 30 additional trials before intervention (TASK), 5 minutes after intervention (TASK5), and 20 minutes after intervention (TASK20). Movement-related EMG signals were recorded to estimate the participants’ reaction time (RT) and monitor their movement performance during the three task-related periods. Transcranial magnetic stimulation (TMS)-evoked EEG responses were collected before intervention (PRE), immediately after intervention (POST0), and 15 minutes after intervention (POST15) using 100 TMS pulses. Stimulus intensity was set at 120% of the resting motor threshold (RMT). Sessions concluded with a resting state 25 minutes after intervention (post-REST). The intervention provider has over 10 years of experience using TMS, EEG, and electromyography (EMG) technology. Throughout the experiment, participants sat in a comfortable chair and rested their right-hand index finger on a keypad without electronic devices. EMG signals were recorded from the right hand's first dorsal interosseous (FDI) and abductor digiti minimi (ADM) muscles. Repetitive TMS (rTMS) was administered at a frequency of 10Hz, with 1200 pulses delivered over a 10-minute stimulation duration. TMS pulses were delivered over the M1 of the FDI “hot spot” where the largest motor-evoked potentials (MEPs) could be acquired. The interventions consisted of 90 trials of a movement task, during which 10Hz rTMS at 80% of the RMT with 1200 pulses over a 10-minute stimulation duration was implemented. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Transcranial magnetic stimulation device |
| Primary outcome measure | The following primary outcome measures were assessed using electromyography before intervention (TASK), 5 min after intervention (TASK5), and 20 min after intervention (TASK 20): 1. Reaction time, characterized between the ‘0’ cue and feedback 2. Movement performance, defined as the percentage of the sum of OK and GOOD among total trials |
| Secondary outcome measures | Motor cortical excitability measured using electroencephalography (EEG) during a resting state with eye open (pre-REST), 0 min after intervention (POST0) and with a resting state 25 min after intervention (post-REST) |
| Overall study start date | 05/09/2021 |
| Completion date | 16/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Criteria specified in the TMS safety guidelines 2. Right-handed hand 3. Age range: 20-75 years old 4. No metal implants on the head 5. Healthy, No neurological or psychiatric disorders 6. No severe visceral diseases such as liver, lung, heart, kidney, etc 7. Voluntarily participate and sign an informed consent form 8. No severe motor function and able to complete exercise tests 9. Not receiving any drug treatment |
| Key exclusion criteria | 1. A history of neurological or psychiatric disorders 2. Receiving any drug treatment 3. Unwilling to have TMS 4. Unwilling to record EEG 5. Contraindications to magnetic stimulation |
| Date of first enrolment | 05/04/2022 |
| Date of final enrolment | 09/08/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Qinhuangdao
066000
China
Sponsor information
University/education
Key Laboratory of Intelligent Rehabilitation and Neuromodulation of Hebei Province, No.438 Hebei Street West Section
Qinhuangdao City, Hebei Province
066000
China
| Phone | +86 15022071790 |
|---|---|
| ldfu@ysu.edu.cn | |
| Website | https://www.ysu.edu.cn/ |
"ROR" |
https://ror.org/02txfnf15 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- 重点基础研究发展计划, National Basic Research Program of China (973 Program), Special Fund for the National Key Research and Development Plan, China National Key Research and Development Plan Project, National Key Research and Development of China, National Key Research and Development Program, National Key R&D Program of China, National Key R&D Programmes of China, China's National Key R&D Programmes, National Basic Research Program of China, 973 Program, National Program on Key Basic Research Project (973 Program), National Plan on Key Basic Research and Development, National Basic Research Program, NKRDPC, NKPs
- Location
- China
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 12/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The data is owned by the Sponsor and Key Laboratory of Intelligent Rehabilitation and Neuromodulation of Hebei Province. Scientific audience The protocol for the study will be published in a peer-reviewed journal and the results of the study presented at National and International meetings on behalf of Key Laboratory of Intelligent Rehabilitation and Neuromodulation of Hebei Province. These publications and presentations will acknowledge the sponsor and funder of the study. On completion of the trial, the data will be analysed, and tabulated, and final study reports will be sent to the relevant authorities (funder, Ethics Committee of the First Hospital of Qinhuangdao). The primary outcome paper will be submitted to an open-access peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon reasonable request at the end of the study from Dr Lingdi Fu, ldfu@ysu.edu.cn. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 10/10/2024 | No | No |
Additional files
Editorial Notes
10/10/2024: Study's existence confirmed by the Ethics Committee of First Hospital of Qinhuangdao.
