Effect of low frequency repetitive transcranial magnetic stimulation on sleep disturbance in patients with amyotrophic lateral sclerosis.

• Register: ChiCTR
• Last refreshed on: 12 June 2023
• Main ID: ChiCTR2300071373
• Date of registration: 2023-05-12
• Prospective Registration: Yes
• Primary sponsor: Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)
• Public title: Effect of low frequency repetitive transcranial magnetic stimulation on sleep disturbance in patients with amyotrophic lateral sclerosis.
• Scientific title: Effect of low frequency repetitive transcranial magnetic stimulation on sleep disturbance in patients with amyotrophic lateral sclerosis.
• Date of first enrolment: 2023-05-12
• Target sample size: Routine rehabilitation training group + low frequency repetitive transcranial magnetic stimulation group:30;Routine rehabilitation training + low frequency repetitive transcranial magnetic stimulation sham stimulation group:30;
• Recruitment status: Pending
• URL: https://www.chictr.org.cn/showproj.html?proj=197264
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Hu yue
• Affiliation: Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

• Name: LAN dan-mei
• Affiliation: Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Key inclusion & exclusion criteria

Inclusion criteria: ? The age range from 18 to 80 years old, male and female;
? All ALS patients met clinically confirmed or probable ALS in the revised E1 Escorial criteria and Pittsburgh sleep quality index (PSQI) score =7;
(3) Mild to moderate disability (ALS-FRSR score: breathing score =3, other scores =2);
(4) To understand the whole process of the test, voluntarily participate in and sign the informed consent, provided by or legally authorized representatives.
? Have the communication ability required to participate in all tests.
Exclusion criteria: ? Patients with unstable disease or unable to cooperate with active training;
? There are listening comprehension disorders, visual impairment, hearing impairment, complete aphasia; Cognitive dysfunction (MMSE<21);
? Had a history of major surgery a week ago;
? Patients with the following complications: 1) severe liver and kidney function injury (ALT, AST, TBiL, Cr more than 50% of the upper limit of normal); 2) Abnormal mental state; 3) Complicated with malignant tumor, or history of malignant tumor;
? Pregnant or lactating women;
? Patients with contraindications of repetitive transcranial magnetic stimulation: such as epilepsy history, metal implantation history or pacemaker implantation history;
? Other conditions in which the investigator considers it impossible to participate in the clinical trial.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic lateral sclerosis

Intervention(s)

Routine rehabilitation training group + low frequency repetitive transcranial magnetic stimulation group:Routine rehabilitation training program, including physical therapy, occupational therapy, speech swallowing therapy, 2 times a day, 30 minutes each time, 5 times a week, 20 times. On the basis of routine intervention, repeated transcranial magnetic stimulation therapy was completed every day, with each treatment lasting 20 minutes, 5 times a week, 20 times.;Routine rehabilitation training + low frequency repetitive transcranial magnetic stimulation sham stimulation group:On the basis of routine intervention, repeated transcranial magnetic stimulation (TMS) sham stimulation was performed daily for 20 minutes, 5 times a week.;

Primary Outcome(s)

Sleep efficiency in polysomnographic monitoring data;

Secondary Outcome(s)

Hamilton depression scale score;Hamilton anxiety scale score;ALSFRS-R score;ALSAQ-40 score;

Source(s) of Monetary Support

Multidisciplinary Management of Amyotrophic lateral Sclerosis, Shanghai Disabled Persons' Federation

Ethics review

Status: Approved
Approval date: 08/02/2023
Contact:

shao ying-qi

[phone]