TRIMLiS
The Effect of Transcranial Direct Current Stimulation Combined With Repetitive Transcranial Magnetic Stimulation on Motor Function Rehabilitation in Patients With Locked-in Syndrome
Sponsor study identifier
interventional
72
0 countries
N/A
Study Start
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2025
Actual (reported)November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2, 2025
Actual (reported)June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
FMA
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
HBFNGS
Before the intervention starts, 1-2 days after the intervention ends, and 1, 3, and 6 months after the intervention ends
Modified Barthel Index
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention
Motor evoked potential（Mep）
Before intervention, 1-2 days after intervention
Assessment of TMS-EEG（TEPs）
Before intervention and 1-2 days after intervention
true tDCS and true rTMS
sham tDCS and true 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.
First Submitted
November 17, 2025
First Posted
December 2, 2025
Study Start
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Transcranial Direct Current Stimulation for Long COVID Brain Fog and Fatigue
true tDCS and sham rTMS
sham tDCS and sham rTMS
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.
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June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 10, 2025
Record last verified: 2025-12
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