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NCT Number: NCT06904716

The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia

Spinocerebellar ataxia (SCA) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. A key pathogenic mechanism of SCA is the repeated expansion of cytosine - adenine - guanine (CAG) trinucleotides in the coding region of specific genes. These repeated expansions are translated into abnormally large polyglutamine (PolyQ) tracts in proteins. These polyglutamine (PolyQ) tracts can cause changes in the excitability of the cerebral cortex in SCA patients. Quantitative electroencephalogram analysis (qEEG) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze EEG signals, bringing new technologies for EEG signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. It is sensitive to early neurodegenerative lesions. Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients. Currently, the exploration of the quantitative electroencephalogram characteristics of SCA patients is still insufficient.

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Key information

Conditions

Spinocerebellar Ataxia 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 Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliatted Hospital of Chongqing medical Uiversity

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Spinocerebellar ataxia patients confirmed through genetic testing
  • Patient aged 18-75
  • Patients who can walk independently (with the aid of a cane/walker) without assistance from others.
  • The SARA score exceeds 3.

Exclusion criteria

  • Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)
  • Patients with significantly abnormal clinical indicators identified during screening
  • Patients concurrently participating in another clinical study
  • Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders
  • Patients with severe heart disease
  • Patients who are wheelchair users
  • pregnant woman
  • Patients who cannot establish their identity or have limited legal capacity
  • Patients with contraindications for rTMS, including metallic objects in the head, history of neurosurgery, ferromagnetic bioimplants, metal coatings, history of seizures, autism, current use of protease inhibitors or other medications that may increase the risk of rTMS-induced seizures.

Treatment and study plan

Transcranial magnetic stimulation

Other

Repetitive transcranial magnetic stimulation

Primary outcomes

  1. Scale for the assessment and rating of ataxia

    Time frame: Baseline and one week post-baseline (after treatment)

    The Scale for the Assessment and Rating of Ataxia (SARA) is a clinical tool used to assess the severity of ataxia. The total score range of the SARA scale is 0 to 40 points, with higher scores indicating more severe ataxia symptoms.

  2. Resting - state electroencephalogram

    Time frame: baseline and one week post-baseline (after treatment)

    Use electroencephalogram (EEG) to collect the electroencephalogram data of participants with their eyes closed and in a waking state.Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.

  3. Transcranial Magnetic Stimulation - Electroencephalogram（TMS-EEG）

    Time frame: Baseline and one week post-baseline (after treatment)

    Transcranial magnetic stimulation is utilized to stimulate the brain, and then EEG data is immediately collected from participants using EEG to collect closed-eye, awake EEG data.Using time-frequency analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.

Secondary outcomes

  1. The International Cooperative Ataxia Rating Scale (ICARS)

    Time frame: Baseline and one week post-baseline (after treatment)

    The International Cooperative Ataxia Rating Scale (ICARS) is a widely used clinical tool designed to assess the severity of ataxia, particularly in patients with cerebellar disorders. The total score range of the ICARS scale is 0 to 100 points, with higher scores indicating more severe ataxia symptoms.

  2. The Neurological Examination Score for the assessment of Spinocerebellar Ataxias (NESSCA)

    Time frame: Baseline and one week post-baseline (after treatment)

    The Neurological Examination Score for the Assessment of Spinocerebellar Ataxias (NESSCA) is a clinical tool specifically designed to evaluate the severity of spinocerebellar ataxias (SCAs).The total score range of the NESSCA scale is 0 to 60 points, with higher scores indicating more severe ataxia symptoms.

  3. The EQ Visual Analogue Scale

    Time frame: Baseline and one week post-baseline (after treatment)

    The EQ Visual Analogue Scale (EQ-VAS) is a component of the EuroQol Five Dimensions Questionnaire (EQ-5D) used to assess a patient's subjective perception of their overall health.The EQ-VAS ranges from 0 to 100. 0: Represents "the worst imaginable health state." 100: Represents "the worst imaginable health state." High scores (closer to 100): Indicate that the patient perceives their health as very good.Low scores (closer to 0): Indicate that the patient perceives their health as very poor.

  4. Gait analysis

    Time frame: Baseline and one week post-baseline (after treatment)

    The researchers use gait sensors to collect gait data

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

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

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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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