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

Chulalongkorn University

Status: Enrolling

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Treatments: Device: Sham rTMS; Device: Personalized rTMS; Device: Standard rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07067229

COA No. 1142/2024

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged between 18 and 80 years
• 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

• History of other neurological disorders, such as stroke
• Use of ventilatory support
• Severe dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Personalized intervention group

Experimental group

Description:

Participants will receive personalised repetitive transcranial magnetic stimulation mixed reality.

Treatment:

Device: Personalized rTMS

Standard intervention group

Active Comparator group

Description:

Participants will receive standard repetitive transcranial magnetic stimulation plus mixed reality.

Treatment:

Device: Standard rTMS

Sham group

Sham Comparator group

Description:

Participants will receive sham repetitive transcranial magnetic stimulation mixed reality.

Treatment:

Device: Sham rTMS