Individualized Functional Imaging-Guided Repetitive Trans... | NCT06819358

Studies
Individualized Functional Imaging-Guided Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Postural Gait Disorders in Patients with Amyotrophic Lateral Sclerosis (ALS): a Randomized, Crossover, Controlled, Double-Blind Clinical Study

NCT06819358

Sponsor

Peking University Third Hospital

Status

Not yet recruiting

Last Update Posted

Feb 11, 2025Actual

Enrollment

45Estimated

Phase

Early Phase 1

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

Transcranial Magnetic Stimulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2025Estimated

Primary Completion Date

Mar 15, 2026Estimated

Completion Date

Mar 15, 2026Estimated

First Submitted Date

Jan 23, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 11, 2025Actual

Name	Class
Changping Laboratory	OTHER

Description Module

Brief Summary

This study is a randomized, crossover, controlled, double-blind clinical trial. Patients (n=45) were randomly divided into Group A and Group B. Patients in Group A will receive 2 weeks (10800 Hz daily, 5 days×2) of Transcranial magnetic stimulation（TMS） treatment, while patients in Group B will receive sham stimulation with the same frequency. After a 4-week washout period, the two groups cross over. Patients in Group A will receive sham stimulation, and patients in Group B will receive TMS treatment for 2 weeks (10800 Hz daily, 5 days×2). Clinical functional scales, imaging evaluations, and gait analysis will be conducted at baseline, after 2 weeks of treatment, before crossover treatment, and after 2 weeks of crossover treatment. The therapist, patients, and assessors will be all blinded throughout the study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator		Device: Transcranial Magnetic Stimulation
Group B	Sham Comparator		Device: Transcranial Magnetic Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation	Device	Patients in Group A will receive 2 weeks (10800 Hz daily, 5 days×2) of TMS treatment, while patients in Group B will receive sham stimulation with the same frequency. After a 4-week washout period, the two groups cross over. Patients in Group A will receive sham stimulation, and patients in Group B will receive TMS treatment for 2 weeks (10800 Hz daily, 5 days×2).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scale evaluation	The Berg Balance Scale (BBS) assesses static and dynamic balance. The scale ranges from 0 to 56, with higher scores indicating better balance and lower scores signifying greater fall risk.	Baseline (Week 0), Week 2, Week 6, Week 8

Secondary Outcomes

Measure	Description	Time Frame
Scale evaluation	Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score(ALSFRS-R total score).The ALSFRS-R evaluates functional impairment in ALS patients. The total score ranges from 0 to 48, with higher scores reflecting better functional ability.	Baseline (Week 0), Week 2, Week 6, Week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18-80 years;
Diagnosis of motor neuron disease at probable level or above based on Estorial criteria;12
Meet UMND ALS diagnosis criteria: at least three segments of upper motor neuron damage localized to 1-2 muscles, or EMG indicating loss of innervation in 1-2 muscles;13
Presence of lower limb dysfunction: Berg balance scale score below 40;
Capable of standing independently for more than 30 seconds and able to walk or walk with assistance;
Stable medication dosage for at least one month;
FVC > 60%;
Signed informed consent.

Exclusion Criteria:

History of substance abuse within the past 6 months;
History of epilepsy or first-degree relative with epilepsy;
Patients with severe systemic diseases in the heart, lungs, liver, or kidneys that cannot be controlled with routine medications, based on laboratory results;
Patients with severe depression or anxiety (HAMD-17 score ≥18; HAMA score ≥21) or diagnosed with other mental illnesses;
Patients with a life expectancy of less than one year due to reasons other than neurodegenerative diseases;
Pregnant women or those planning to become pregnant;
Individuals with a pacemaker, cochlear implant, or other metallic foreign bodies and any implanted electronic equipment, or those with contraindications for MRI scanning or TMS treatment, such as claustrophobia;
Patients who have received TMS, transcranial electrical stimulation, transcranial focused ultrasound, or other neuromodulation treatments within three months prior to enrollment;
Other abnormal examination results deemed unsuitable for participation by the research investigator;
Inability to cooperate for follow-ups due to geographical or other reasons;
Participation in other clinical research trials.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ji He	Contact	+86 15801224009		15801224009@163.COM

Intervention Model Description

This study is a randomized, crossover, controlled, double-blind clinical trial. Patients (n=45) were randomly divided into Group A and Group B. Patients in Group A will receive 2 weeks (10800 Hz daily, 5 days×2) of TMS treatment, while patients in Group B will receive sham stimulation with the same frequency. After a 4-week washout period, the two groups cross over. Patients in Group A will receive sham stimulation, and patients in Group B will receive TMS treatment for 2 weeks (10800 Hz daily, 5 days×2). Clinical functional scales, imaging evaluations, and gait analysis will be conducted at baseline, after 2 weeks of treatment, before crossover treatment, and after 2 weeks of crossover treatment. The therapist, patients, and assessors will be all blinded throughout the study.

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D051346	Mobility Limitation

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease
D019636	Neurodegenerative Diseases
D057177	TDP-43 Proteinopathies
D009468	Neuromuscular Diseases
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics