Amyotrophic Lateral Sclerosis (ALS)Early Phase 1iFIRST-ALSNCT06819358
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
A Early Phase 1 study testing Transcranial Magnetic Stimulation in people with Amyotrophic Lateral Sclerosis (ALS), run by Peking University Third Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2025to 15 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Individualized cortical mapping technology, repetitive transcranial magnetic stimulation, amyotrophic lateral sclerosis, balance and gait disorders.
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Device: Transcranial Magnetic Stimulation |
| Group B | Sham comparator | Not described Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Secondary outcomes (7)
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.
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Scale evaluation
Walking and stepping sub-items, Modified Ashworth Scale (MAS),The scale ranges from 0 to 4, with higher scores indicating greater spasticity.
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Scale evaluation
Timed Instant Walking (TUG) tes,the TUG test measures mobility and fall risk. Lower times indicate better mobility.
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Scale evaluation
10-meter walking test time (10MWT),This test measures walking speed over a 10-meter distance. Lower times indicate faster walking speed
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Imaging evaluation
Functional MRI (fMRI) - Brain Function and Cortical Excitatory Changes, fMRI will assess changes in brain function and cortical excitability.Functional MRI (fMRI) is a neuroimaging technique used to assess brain function by detecting changes in blood oxygen levels (BOLD signal), which reflect neural activity. In this study, fMRI will be used to evaluate brain function and cortical excitability in patients with schizophrenia. Specifically, it will assess neural activation patterns in response to cognitive and emotional tasks designed to probe social cognition, emotion recognition, and executive functions. Areas of interest include the prefrontal cortex, amygdala, and visual processing regions involved in emotion processing and decision-making.fMRI will be performed as follows:Participants will be scanned while completing emotion recognition tasks to identify brain regions activated during these tasks.Scans will be conducted in a resting-state condition as well, to measure baseline cort
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Gait instrument
Gait Assessment and Fall Index (Tetrax Instrument),Gait and fall risk assessment will be conducted using the Tetrax instrument. Data will be analyzed as index. The Fall Index Assessment is conducted using the Tetrax instrument, which is a widely used device for evaluating balance and fall risk. The Tetrax system consists of a set of sensors placed on the patient's feet to measure their ability to maintain balance in various postural positions, including static (standing still) and dynamic (movement) tasks. The system evaluates several components of balance, including:Postural Sway: The extent of body movement while standing;Stability: The ability to maintain a balanced posture under different conditions;Response Time: How quickly the subject can correct their posture after perturbation (e.g., slight push)；Foot Pressure Distribution: How evenly weight is distributed between the feet while standing.
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
biological indicator
Neurofilament protein (NFL),NFL levels will be measured in blood samples to assess neurodegeneration.Neurofilament light chain (NFL) is measured in peripheral blood samples using the SIMOA (Single Molecule Array) assay, a highly sensitive technique that quantifies NFL levels at the single-molecule level. NFL concentration is expressed in pg/mL, with higher levels indicating greater neuronal injury or neurodegeneration.
Measured: Baseline (Week 0), Week 2, Week 6, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start14 Feb 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changping Laboratory
- Responsible party
- Principal investigator, He Ji, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819358
- Sponsor's protocol ID
- M2024877
- Acronym
- iFIRST-ALS
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06819358
- Acronym / sponsor ID
- iFIRST-ALS / M2024877
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Individualized cortical mapping technology, repetitive transcranial magnetic stimulation, amyotrophic lateral sclerosis, balance and gait disorders.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Changping Laboratory
- Study start
- 14 Feb 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Transcranial Magnetic Stimulation |
| Group B | Sham comparator | Device: Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationPatients 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). | Device | Group A, Group B |
Primary outcome
Scale evaluation
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
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.
7 secondary outcomes
Scale evaluation
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
Scale evaluation
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
Scale evaluation
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
Scale evaluation
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
Imaging evaluation
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
Gait instrument
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
biological indicator
Time frame: Baseline (Week 0), Week 2, Week 6, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transcranial Magnetic Stimulation in people with Amyotrophic Lateral Sclerosis (ALS), run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji He (+86 15801224009, 15801224009@163.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale evaluation (time frame: Baseline (Week 0), Week 2, Week 6, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.