TDCS-RTMS Intervention for Motor Function

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

Overview

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.

Interventions

• 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, i
• 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

Primary outcome measures

• the efficiency [Time frame: Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07257601 · L20251115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗