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NCT Number: NCT05502432

Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide.Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy used to treat depression and cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a 15 day treatment with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) can improve symptoms (motor symptoms and non-motor symptoms) in patients with MJD.

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Key information

Conditions

Spinocerebellar Ataxia Type 3 Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Machado-Joseph Disease Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology ,First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

About this study

Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide. MJD shows remarked clinical heterogeneity and presents with various clinical manifestations, including cerebellar ataxia, limb incoordination, dysarthria, sleep disorders, axonal neuropathy, dystonia, pyramidal signs and, diplopia. No effective treatment is currently available for MJD.

Repetitive transcranial magnetic stimulation (rTMS)enables non-invasive modulation of cortical excitability. rTMS targeting cerebellar structures is capable of inducing long-lasting changes in the excitability of cerebello-thalamocortical pathways.

Subjects will be randomized in two groups, one receiving a consecutive 15-day treatment with 1 Hz of repetitive transcranial magnetic stimulation and the other receiving sham stimulation with identical parameters. Patients will be clinically assessed at baseline, during intervention period at 7 days and 15 days immediate after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1 .Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3.

  • SCA3 patients aged 20 - 80 years 3. Patients or their family members have informed consent to the study and signed relevant documents

Exclusion criteria

  • 1. Patients who have concomitant epilepsy. 2. History of seizure or heat convulsion. 3. Patients on neuroleptics. 4. History or current unstable hypertension. 5. History of head injury or neurosurgical interventions. 6. History of any metal in the head (outside the mouth). 7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
  • History of frequent or severe headaches. 9. History of migraine. 10. History of hearing loss. 11. History of cochlear implants 12. History of drug abuse or alcoholism. 13. Pregnancy or not using a reliable method of birth control. 14. Participation in current clinical study.

Treatment and study plan

Active Repetitive Transcranial Magnetic Stimulation

Device

Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

Device

Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation

Primary outcomes

  1. ICARS

    Time frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment.

    The International Cooperative Ataxia Rating Scale (ICARS)

Secondary outcomes

  1. BBS

    Time frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment

    Berg Balance Scale (BBS)

  2. SARA

    Time frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment

    Scale for the Assessment and Rating of Ataxia (SARA)

Other outcomes

  1. Tandem gait

    Time frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment

    Tandem gait is a gait (method of walking or running) where the toes of the back foot touch the heel of the front foot at each step.

  2. 10 Metre Walk Test

    Time frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment

    The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

  3. Static Stability Test

    Time frame: At baseline and 15 days immediate after treatment

    Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At baseline and 15 days immediate after treatment

    The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used instrument to assess the subjective sleep quality of adults in clinical and community settings

  5. Athens Insomnia Scale (AIS)

    Time frame: At baseline and 15 days immediate after treatment

    The AIS is a self-reported questionnaire designed to measure the severity of insomnia based on the diagnostic criteria of the International Classification of Diseases, 10th revision (ICD-10).

  6. Mini-Mental State Examination (MMSE)

    Time frame: At baseline and 15 days immediate after treatment

    In addressing cognitive screening tools, the MMSE and the MoCA are the most commonly used methods in cognitive impairment detection in both clinical and research fields.

  7. Montreal Cognitive Assessment (MoCA）

    Time frame: At baseline and 15 days immediate after treatmen

    In addressing cognitive screening tools, the MMSE and the MoCA are the most commonly used methods in cognitive impairment detection in both clinical and research fields.

  8. Hamilton Anxiety Scale (HAMA)

    Time frame: At baseline and 15 days immediate after treatmen

    HAMA contains 14 questions; each question includes 5 items. Responses are scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (extremely serious). The total score of HAMA is operationally categorized as follows: no anxiety (score 0-6), mild and moderate anxiety (score 7-13), severe anxiety (score ≥ 14).

  9. Hamilton Depression Scale (HAMD)

    Time frame: At baseline and 15 days immediate after treatmen

    HAMD contains 17 questions; each question includes 5 items. Responses are scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (extremely serious). The total score of HAMD can be classified into normal (score 0-6), mild and moderate (score 7-23), severe depression (score ≥ 24).

Sponsors and collaborators

Lead sponsor

Ning Wang, MD., PhD.

Other

Registry information

Official study title

A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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