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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071373

Enrollment

Unknown

Registered

2023-05-12

Start date

2023-05-12

Completion date

Unknown

Last updated

2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis

Interventions

Routine rehabilitation training group + low frequency repetitive transcranial magnetic stimulation group:Routine rehabilitation training program, including physical therapy, occupational therapy, spee

Routine rehabilitation training + low frequency repetitive transcranial magnetic stimulation sham stimulation group:On the basis of routine intervention, repeated transcranial magnetic stimulation (TM

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion 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

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.

Design outcomes

Secondary

Measure	Time frame
Hamilton depression scale score;Hamilton anxiety scale score;ALSFRS-R score;ALSAQ-40 score;	—

Primary

Measure	Time frame
Sleep efficiency in polysomnographic monitoring data;	—

Countries

China

Contacts

Public ContactLAN dan-mei

Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

landanmei2013@163.com+86 185 2130 8136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026