TDCS-RTMS Intervention for Motor Function
ConditionLocked in Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhujiang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Repetitive transcranial magnetic stimulation
DeviceThe 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 stimulation
DeviceDeliver 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.
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Placebo comparator 2 interventions
Group C: Group 3Placebo comparator 2 interventions
Group D: Group 4Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after interventionSecondary outcomes
1
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.
Time frame
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention2
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.
Time frame
Before the intervention starts, 1-2 days after the intervention ends, and 1, 3, and 6 months after the intervention ends3
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.
Time frame
Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention4
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.
Time frame
Before intervention, 1-2 days after interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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