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

NCT ID: NCT07067229

Last Updated: 2025-09-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-12-30

Brief Summary

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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

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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

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ALS (Amyotrophic Lateral Sclerosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Personalized intervention group

Participants will receive personalised repetitive transcranial magnetic stimulation mixed reality.

Group Type EXPERIMENTAL

Personalized rTMS

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Standard rTMS

Intervention Type DEVICE

Standard repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise

Sham group

Participants will receive sham repetitive transcranial magnetic stimulation mixed reality.

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

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

Intervention Type DEVICE

Standard rTMS

Standard repetitive transcranial magnetic stimulation (TMS) together with mixed-reality (MR) exercise

Intervention Type DEVICE

Sham rTMS

Sham rTMS together with mixed-reality (MR) exercise

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Jakkrit Amornvit, MD

Role: CONTACT

Thailand: 88-951-9195

Phunsuk Kantha, PT.,PhD

Role: CONTACT

Thailand: 93-295-1646

Facility Contacts

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Jakkrit Amornvit, MD

Role: primary

+66622169338

Phuettha Sangrut, MSc

Role: backup

6622564000 ext. 80722

Other Identifiers

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COA No. 1142/2024

Identifier Type: -

Identifier Source: org_study_id

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