Non-invasive Brain Stimulation and Exercise Intervention for Patients With Motor Neuron Disease
NCT ID: NCT07067229
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-01
2027-12-30
Brief Summary
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Detailed Description
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The baseline assessments will be as follow:
1. Demographic information such as age, sex, body height, body weight, body mass index, date of diagnosis, type of MND, and current medications.
2. Questionnaires including amyotrophic lateral sclerosis functional rating scale - revised version (ALSFRS-R), penn upper motor neuron score (PUMNS), patient health questionnaire (PHQ-9), and EuroQol 5-Dimension 5-level (EQ-5D-5L).
3. Clinical assessments including hand grip test, pinch grip test, and hand function.
4. Lung function tests such as forced vital capacity (FVC).
5. Neurophysiological assessment by using transcranial magnetic stimulation (TMS)
6. Electromyography (EMG) including compound muscle action potential (CMAP), motor unit number estimation (MScan fit-MUNE), and motor unit number index (MUNIX).
7. Magnetic resonance imaging (MRI)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Personalized intervention group
Participants will receive personalised repetitive transcranial magnetic stimulation mixed reality.
Personalized rTMS
Personalized repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
Standard intervention group
Participants will receive standard repetitive transcranial magnetic stimulation plus mixed reality.
Standard rTMS
Standard repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
Sham group
Participants will receive sham repetitive transcranial magnetic stimulation mixed reality.
Sham rTMS
Sham rTMS together with mixed-reality (MR) exercise
Interventions
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Personalized rTMS
Personalized repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
Standard rTMS
Standard repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
Sham rTMS
Sham rTMS together with mixed-reality (MR) exercise
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with any type of motor neuron disease (MND)
* Have mild to moderate severity, as assessed by the Sinaki-Mulder scale, with a severity level between 1 and 3
Exclusion Criteria
* Use of ventilatory support
* Severe dementia
18 Years
80 Years
ALL
No
Sponsors
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King Chulalongkorn Memorial Hospital
OTHER
Chulalongkorn University
OTHER
Responsible Party
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Principal Investigators
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Jakkrit Amornvit, MD
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Phunsuk Kantha, PT.,PhD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Kulvara Lapanan, PT
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University and Neuroscience Resesarch Australia
Locations
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King Chulalongkorn Memorial hospital, The Thai Red Cross Society
Bangkok, Pathumwan, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COA No. 1142/2024
Identifier Type: -
Identifier Source: org_study_id
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