TDCS-RTMS Intervention for Motor Function (TRIMLiS)

December 2, 2025 updated by: Qiuyou Xie, Zhujiang Hospital

The Effect of Transcranial Direct Current Stimulation Combined With Repetitive Transcranial Magnetic Stimulation on Motor Function Rehabilitation in Patients With Locked-in Syndrome

This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University. It is planned to recruit 72 eligible patients with atresia syndrome and randomly divide them into four groups according to the ratio of 1:1:1:1. Group 1 received the sequential stimulation of true tDCS and true rTMS, group 2 received the stimulation of sham tDCS and then true rTMS, group 3 received the stimulation of true tDCS and then sham rTMS, and group 4 received the simulated stimulation of sham tDCS and sham rTMS. The patients were treated for 4 weeks, 5 days a week, once a day in the bilateral M1 area, and in the morning and afternoon on the left and right sides respectively. Each tDCS and rTMS treatment lasted for 20 minutes.Various indicators were evaluated before and after the intervention, and the observation and follow-up were conducted 1, 3, and 6 months after the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University. It is planned to recruit 72 eligible patients with atresia syndrome and randomly divide them into four groups according to the ratio of 1:1:1:1. Group 1 received the sequential stimulation of true tDCS and true rTMS, group 2 received the stimulation of sham tDCS and then true rTMS, group 3 received the stimulation of true tDCS and then sham rTMS, and group 4 received the simulated stimulation of sham tDCS and sham rTMS. The patients were treated for 4 weeks, 5 days a week, once a day in the bilateral M1 area, and in the morning and afternoon on the left and right sides respectively. Transcranial direct current stimulation (tDCS) was performed using a 2 Ma DC stimulator. The anode was placed in the M1 area of the target side (corresponding to the electrode position c3/c4 of the 10-20 EEG system), and the cathode was placed on the contralateral shoulder. The left side was done in the morning and the right side was done in the afternoon. Each tDCS treatment lasted for 20 minutes. The sham stimulation was given current stimulation for 30 seconds and gradually decreased to 0. Repetitive transcranial magnetic stimulation (rTMS) intervention was performed 20 minutes after the end of TDCS treatment. RTMS uses an 8-shaped coil placed in the M1 area of the target side to stimulate at a frequency of 10Hz. Each treatment contains 1600 pulses of stimulation for 4 seconds, with an interval of 26 seconds. The total number of pulses is 1600, lasting for 20 minutes. Each time is once a day in the M1 area of both sides. The sequence is the same as that of TDCS, 5 days a week, and the same lasts for 4 weeks. The stimulation coil was placed at 90 degrees during sham stimulation. Various indicators were evaluated before and after the intervention, and the observation and follow-up were conducted 1, 3, and 6 months after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patients were 18-70 years old, clinically diagnosed as classic or incomplete atresia syndrome, and the onset time was 6 weeks-1 year.
  • Clear consciousness, effective communication and command response through eye movement or other established methods.
  • No drugs (sodium, calcium channel blockers or sedatives) that may affect neuromuscular function or brain stimulation effect were used, or the drugs were stably stopped for more than 1 week before enrollment.
  • The patient or his legal guardian signed the informed consent form and agreed to cooperate in completing all test procedures and evaluations.

Exclusion Criteria:

  • Metal implants (such as cardiac pacemaker, intracranial metal clip, etc.), electronic equipment or other TMS contraindications.
  • Complicated with severe cognitive impairment (such as dementia) or unable to cooperate to complete the assessment scale test.
  • Have a history of severe cardiopulmonary dysfunction, mental illness and seizures.
  • There are other neurodegenerative diseases that affect the recovery of motor function (such as amyotrophic lateral sclerosis, etc.)
  • Recently (within 1 month) participated in other clinical trials related to neuromodulation therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
true tDCS and true rTMS
Device: Repetitive transcranial magnetic stimulation
The stimulation intensity is determined by the individual resting motor threshold (RMT), which is the lowest TMS intensity that the target muscle (such as abductor pollicis brevis) can produce EMG signals with peak to peak values greater than 50 μ V at least 5 times in 10 stimuli by stimulating the motor cortex (M1 area). The actual stimulus intensity was 90% of RMT. Using an 8-shaped coil, locate the M1 area on both sides successively (left side in the morning and right side in the afternoon, in the same order as tDCS). Each treatment included 1600 pulses, 4 seconds of stimulation, with an interval of 26 seconds. Each hemisphere was stimulated once a day for 5 consecutive working days. The unilateral M1 area was stimulated 20 times for 4 weeks, and each stimulation lasted 20 minutes. The real rTMS group and the sham rTMS group were treated with the same regimen. The coil was placed 90 degrees perpendicular to the scalp surface with the same parameters as the active rTMS.
Other Names:
  • rTMS
Device: Transcranial direct current stimulation
Deliver 2mA DC power through a 5 × 5 cm ² sponge electrode, with the anode placed in the M1 area on one side (left side in the morning and right side in the afternoon) and the cathode placed on the opposite shoulder. Each tDCS treatment lasts for a fixed time of 20 minutes throughout the day, approximately 20 minutes before rTMS treatment, five days a week, with a total of 20 sessions in the unilateral M1 area for a total of 4 weeks. The true tDCS group and the false tDCS group received the same treatment plan. For the false tDCS group, patients felt electrical stimulation within 30 seconds, and then the current gradually decreased to 0mA.
Other Names:
  • tDCS
Placebo Comparator: Group 2
sham tDCS and true rTMS
Device: Repetitive transcranial magnetic stimulation
The stimulation intensity is determined by the individual resting motor threshold (RMT), which is the lowest TMS intensity that the target muscle (such as abductor pollicis brevis) can produce EMG signals with peak to peak values greater than 50 μ V at least 5 times in 10 stimuli by stimulating the motor cortex (M1 area). The actual stimulus intensity was 90% of RMT. Using an 8-shaped coil, locate the M1 area on both sides successively (left side in the morning and right side in the afternoon, in the same order as tDCS). Each treatment included 1600 pulses, 4 seconds of stimulation, with an interval of 26 seconds. Each hemisphere was stimulated once a day for 5 consecutive working days. The unilateral M1 area was stimulated 20 times for 4 weeks, and each stimulation lasted 20 minutes. The real rTMS group and the sham rTMS group were treated with the same regimen. The coil was placed 90 degrees perpendicular to the scalp surface with the same parameters as the active rTMS.
Other Names:
  • rTMS
Device: Transcranial direct current stimulation
Deliver 2mA DC power through a 5 × 5 cm ² sponge electrode, with the anode placed in the M1 area on one side (left side in the morning and right side in the afternoon) and the cathode placed on the opposite shoulder. Each tDCS treatment lasts for a fixed time of 20 minutes throughout the day, approximately 20 minutes before rTMS treatment, five days a week, with a total of 20 sessions in the unilateral M1 area for a total of 4 weeks. The true tDCS group and the false tDCS group received the same treatment plan. For the false tDCS group, patients felt electrical stimulation within 30 seconds, and then the current gradually decreased to 0mA.
Other Names:
  • tDCS
Placebo Comparator: Group 3
true tDCS and sham rTMS
Device: Repetitive transcranial magnetic stimulation
The stimulation intensity is determined by the individual resting motor threshold (RMT), which is the lowest TMS intensity that the target muscle (such as abductor pollicis brevis) can produce EMG signals with peak to peak values greater than 50 μ V at least 5 times in 10 stimuli by stimulating the motor cortex (M1 area). The actual stimulus intensity was 90% of RMT. Using an 8-shaped coil, locate the M1 area on both sides successively (left side in the morning and right side in the afternoon, in the same order as tDCS). Each treatment included 1600 pulses, 4 seconds of stimulation, with an interval of 26 seconds. Each hemisphere was stimulated once a day for 5 consecutive working days. The unilateral M1 area was stimulated 20 times for 4 weeks, and each stimulation lasted 20 minutes. The real rTMS group and the sham rTMS group were treated with the same regimen. The coil was placed 90 degrees perpendicular to the scalp surface with the same parameters as the active rTMS.
Other Names:
  • rTMS
Device: Transcranial direct current stimulation
Deliver 2mA DC power through a 5 × 5 cm ² sponge electrode, with the anode placed in the M1 area on one side (left side in the morning and right side in the afternoon) and the cathode placed on the opposite shoulder. Each tDCS treatment lasts for a fixed time of 20 minutes throughout the day, approximately 20 minutes before rTMS treatment, five days a week, with a total of 20 sessions in the unilateral M1 area for a total of 4 weeks. The true tDCS group and the false tDCS group received the same treatment plan. For the false tDCS group, patients felt electrical stimulation within 30 seconds, and then the current gradually decreased to 0mA.
Other Names:
  • tDCS
Placebo Comparator: Group 4
sham tDCS and sham rTMS
Device: Repetitive transcranial magnetic stimulation
The stimulation intensity is determined by the individual resting motor threshold (RMT), which is the lowest TMS intensity that the target muscle (such as abductor pollicis brevis) can produce EMG signals with peak to peak values greater than 50 μ V at least 5 times in 10 stimuli by stimulating the motor cortex (M1 area). The actual stimulus intensity was 90% of RMT. Using an 8-shaped coil, locate the M1 area on both sides successively (left side in the morning and right side in the afternoon, in the same order as tDCS). Each treatment included 1600 pulses, 4 seconds of stimulation, with an interval of 26 seconds. Each hemisphere was stimulated once a day for 5 consecutive working days. The unilateral M1 area was stimulated 20 times for 4 weeks, and each stimulation lasted 20 minutes. The real rTMS group and the sham rTMS group were treated with the same regimen. The coil was placed 90 degrees perpendicular to the scalp surface with the same parameters as the active rTMS.
Other Names:
  • rTMS
Device: Transcranial direct current stimulation
Deliver 2mA DC power through a 5 × 5 cm ² sponge electrode, with the anode placed in the M1 area on one side (left side in the morning and right side in the afternoon) and the cathode placed on the opposite shoulder. Each tDCS treatment lasts for a fixed time of 20 minutes throughout the day, approximately 20 minutes before rTMS treatment, five days a week, with a total of 20 sessions in the unilateral M1 area for a total of 4 weeks. The true tDCS group and the false tDCS group received the same treatment plan. For the false tDCS group, patients felt electrical stimulation within 30 seconds, and then the current gradually decreased to 0mA.
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the efficiency
Time Frame: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
An increase of 5 points in the Fugl Meyer Assessment (FMA) score or an increase of one level in the House Brackmann Facial Nerve Grading Scale (HBFNGS) score is considered effective through behavioral assessment.
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FMA
Time Frame: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
FMA comprehensively covers the assessment of upper and lower limb motor function. In the upper limbs, a detailed assessment was conducted on the motor abilities of the shoulders, elbows, wrists, and hands, including joint range of motion, muscle strength, coordination, and fine motor control.
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
HBFNGS
Time Frame: Before the intervention starts, 1-2 days after the intervention ends, and 1, 3, and 6 months after the intervention ends
It is a specialized assessment scale for facial nerve injury, which divides facial nerve function into six levels, from normal to complete paralysis, and provides a detailed grading evaluation of the motor function of facial expression muscles. It has important application value in the diagnosis, treatment effect evaluation, and prognosis judgment of facial nerve injury.
Before the intervention starts, 1-2 days after the intervention ends, and 1, 3, and 6 months after the intervention ends
Modified Barthel Index
Time Frame: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
Contains 10 activities of daily living (ADLs), including eating, dressing, toileting, personal hygiene, bathing, bed and chair transfer, walking/wheelchair use, going up and down stairs, bowel control, and urination control. The score for each activity is determined by the level of assistance required by the patient to complete the activity, with a maximum score of 10 points. The total score range is 0-100 points.
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
Motor evoked potential（Mep）
Time Frame: Before intervention, 1-2 days after intervention
By transcranial magnetic stimulation or electrical stimulation of the cerebral motor cortex, the excitation of cortical motor neurons is triggered, and the generated electrical impulses are transmitted along the corticospinal tract to the anterior horn motor neurons of the spinal cord, thereby causing corresponding muscle contractions and recording potential changes on the muscle surface. In practical operation, the stimulation electrode is usually placed in a specific motor cortex area of the scalp, while the recording electrode is placed in the muscle belly of the target muscle.
Before intervention, 1-2 days after intervention
Assessment of TMS-EEG（TEPs）
Time Frame: Before intervention and 1-2 days after intervention
TEPs refer to the potential changes generated by the synchronous discharge of cortical neurons after TMS pulse stimulation. These potential changes can be recorded through EEG and synchronized with the timing of TMS pulses. TEPs can be used to study the brain's response to stimuli, such as studying the brain's response to different types of TMS stimuli, as well as studying the brain's response to different stimulus intensities. The morphology and amplitude of TEPs can provide information about the activation and inhibition of cortical neurons in the brain.
Before intervention and 1-2 days after intervention
Assessment of TMS-EEG（oscillation analysis）
Time Frame: Before intervention and 1-2 days after intervention
Oscillations refer to the oscillations generated by synchronous firing of cortical neurons after TMS pulse stimulation. These oscillations can be recorded by EEG and synchronized with the time of TMS pulses. TMS triggered oscillations can be used to study the brain's response to stimuli of different frequencies, such as studying the brain's response to TMS stimuli of different frequencies, as well as studying the brain's response to sound or light stimuli of different frequencies. The frequency and amplitude of TMS triggered oscillations can provide information about the activation and inhibition of cortical neurons in the brain, as well as the brain's response to different types of stimuli.
Before intervention and 1-2 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L20251115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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