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Recruiting NCT07067229

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

No phase Interventional ALS (Amyotrophic Lateral Sclerosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized rTMS, Standard rTMS, Sham rTMS.
Who it may be relevant to
Registry conditions: ALS (Amyotrophic Lateral Sclerosis). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

  • 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

Primary outcome measures

  • Amyotrophic Lateral Sclerosis Functional rating scale - revised version (ALSFRS-R) [Time frame: ALSFRS-R will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Muscle evoke potential (MEP) [Time frame: MEP will be mesured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Motor unit number estimation (MScan fit-MUNE) [Time frame: MScan fit-MUNE will be mesured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Motor unit number index (MUNIX) [Time frame: MUNIX will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Cortical silent period (CSP) [Time frame: Muscle evoke potential will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
Secondary outcome measures (11)
  • Muscle mass [Time frame: Muscle mass will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Body mass index (BMI) [Time frame: BMI will be measured at three time point (baseline, 3-month, 6-month post intervention).]
  • Hand grip test [Time frame: Hand grip test will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Pinch grip test [Time frame: Pinch grip test will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Hand function [Time frame: Hand function will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Penn upper motor neuron score (PUMNS) [Time frame: PUMNS will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Patient health questionnaire (PHQ-9) [Time frame: PHQ-9 will be measured at three time points (baseline, 3-month, and 6-month).]
  • EuroQol 5-Dimension 5-level (EQ-5D-5L) [Time frame: EQ-5D-5L will be measure at three time ponts (baseline, 3-month, and 6-months post intervention).]
  • Forced vital capacity (FVC) [Time frame: FVC will be measured at three time points (baseline, 3-month, and 6-month post intervention).]
  • Magnetic resonance imaging (MRI) [Time frame: Brain imaging using MRI will be measured at three time points (baseline, 3-month and 6-month post intervention).]
  • Compound muscle action potential (CMAP) [Time frame: CMAP will be meausred at three time points (baseline, 3-month, and 6-month post intervention).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • King Chulalongkorn Memorial hospital, The Thai Red Cross Society — Bangkok

Identifiers

NCT: NCT07067229 · COA No. 1142/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗