NCT07067229

Non-invasive Brain Stimulation and Exercise Intervention for Patients With Motor Neuron Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Motor neuron disease (MND) is a progressive neurological disorder involving degeneration of motor neurons, leading to muscle weakness, speech and swallowing difficulties, and respiratory failure. This study aims to develop a novel treatment approach combining personalized repetitive transcranial magnetic stimulation (rTMS) with mixed reality (MR) exercise-based games (exergames) to slow disease progression and improve quality of life. In this randomised controlled trial study will compare three groups: (1) rTMS with MR exercise (personalized intervention), (2) rTMS with MR exercise (standard intervention), and (3) sham rTMS with MR exercise. Outcomes will be assessed at baseline, 3 months, and 6 months post intervention. The long-term goal is to implement this approach in clinical settings to enhance care for people with MND.

Detailed description

After screening process, eligible participants will be invited to visit Chula Neuroscience Center for the baseline assessments which will take proximately 2 hours. 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

• ALS (Amyotrophic Lateral Sclerosis)

Interventions

Type	Name	Description
DEVICE	Personalized rTMS	Personalized repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
DEVICE	Standard rTMS	Standard repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise
DEVICE	Sham rTMS	Sham rTMS together with mixed-reality (MR) exercise

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-30
• Completion: 2027-12-30
• First posted: 2025-07-16
• Last updated: 2025-09-25

Locations

1 site across 1 country: Thailand