Locked in SyndromeTRIMLiSNCT07257601
TDCS-RTMS Intervention for Motor Function
A study testing Repetitive transcranial magnetic stimulation and Transcranial direct current stimulation in people with Locked in Syndrome, run by Zhujiang Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locked in Syndrome
- What is being tested?
- Repetitive transcranial magnetic stimulation and Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Locked in Syndrome
- Being tested
- Repetitive transcranial magnetic stimulation, Transcranial direct current stimulation
- Medical subject headings
- Locked-In Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Also called rTMS
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.
Transcranial direct current stimulationDevice
Also called tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | true tDCS and true rTMS Receives: Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation |
| Group 2 | Placebo comparator | sham tDCS and true rTMS Receives: Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation |
| Group 3 | Placebo comparator | true tDCS and sham rTMS Receives: Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation |
| Group 4 | Placebo comparator | sham tDCS and sham rTMS Receives: Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficiency
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.
Measured: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
Secondary outcomes (6)
FMA
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.
Measured: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
HBFNGS
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.
Measured: Before the intervention starts, 1-2 days after the intervention ends, and 1, 3, and 6 months after the intervention ends
Modified Barthel Index
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.
Measured: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
Motor evoked potential（Mep）
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.
Measured: Before intervention, 1-2 days after intervention
Assessment of TMS-EEG（TEPs）
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.
Measured: Before intervention and 1-2 days after intervention
Assessment of TMS-EEG（oscillation analysis）
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.
Measured: Before intervention and 1-2 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locked in SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiuyou Xie, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257601
- Sponsor's protocol ID
- L20251115
- Acronym
- TRIMLiS
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation Combined With Repetitive Transcranial Magnetic Stimulation on Motor Function Rehabilitation in Patients With Locked-in Syndrome
- ClinicalTrials.gov ID
- NCT07257601
- Acronym / sponsor ID
- TRIMLiS / L20251115
- Conditions
- Locked in Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Dec 2025 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Repetitive transcranial magnetic stimulation, Device: Transcranial direct current stimulationtrue tDCS and true rTMS |
| Group 2 | Placebo comparator | Device: Repetitive transcranial magnetic stimulation, Device: Transcranial direct current stimulationsham tDCS and true rTMS |
| Group 3 | Placebo comparator | Device: Repetitive transcranial magnetic stimulation, Device: Transcranial direct current stimulationtrue tDCS and sham rTMS |
| Group 4 | Placebo comparator | Device: Repetitive transcranial magnetic stimulation, Device: Transcranial direct current stimulationsham tDCS and sham rTMS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationAlso: rTMSThe 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. | Device | Group 1, Group 2, Group 3, Group 4 |
| Transcranial direct current stimulationAlso: tDCSDeliver 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. | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
6 secondary outcomes
FMA
Time frame: 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
Modified Barthel Index
Time frame: 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
Assessment of TMS-EEG（TEPs）
Time frame: Before intervention and 1-2 days after intervention
Assessment of TMS-EEG（oscillation analysis）
Time frame: Before intervention and 1-2 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation and Transcranial direct current stimulation in people with Locked in Syndrome, run by Zhujiang Hospital.
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 5 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: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
the efficiency (time frame: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.