TDCS-RTMS Intervention for Motor Function

NCT07257601 | Not Yet Recruiting

• 1 other identifier: L20251115
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Locked in Syndrome

Outcome Measures

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.

  Before intervention, 1-2 days after intervention, and 1, 3, and 6 months after intervention

Secondary Outcomes (6)

• 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

Study Arms (4)

Group 1

EXPERIMENTAL

true tDCS and true rTMS

Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation

Group 2

PLACEBO COMPARATOR

sham tDCS and true rTMS

Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation

Group 3

PLACEBO COMPARATOR

true tDCS and sham rTMS

Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation

Group 4

PLACEBO COMPARATOR

sham tDCS and sham rTMS

Device: Repetitive transcranial magnetic stimulation; Device: Transcranial direct current stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

Also known as: rTMS

Group 1; Group 2; Group 3; Group 4

Transcranial direct current stimulation DEVICE

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.

Also known as: tDCS

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Locked-In Syndrome

Interventions

Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Quadriplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12