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

NCT06904716 | Active Not Recruiting

• 1 other identifier: 2023-140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinocerebellar Ataxia

Outcome Measures

Primary Outcomes (3)

• Scale for the assessment and rating of ataxia

  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.

  Baseline and one week post-baseline (after treatment)

• Resting - state electroencephalogram

  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.

  baseline and one week post-baseline (after treatment)

• Transcranial Magnetic Stimulation - Electroencephalogram（TMS-EEG）

  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.

  Baseline and one week post-baseline (after treatment)

Secondary Outcomes (4)

• The International Cooperative Ataxia Rating Scale (ICARS)

  Baseline and one week post-baseline (after treatment)

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

  Baseline and one week post-baseline (after treatment)

• The EQ Visual Analogue Scale

  Baseline and one week post-baseline (after treatment)

• Gait analysis

  Baseline and one week post-baseline (after treatment)

Study Arms (2)

Test group

EXPERIMENTAL

Perform low-frequency Transcranial Magnetic Stimulation (TMS) on the left and right cerebellar hemispheres and the vermis of the cerebellum, twice a day for a total of 7 days.

Other: Transcranial magnetic stimulation

Controls

NO INTERVENTION

The healthy control group does not receive any intervention.

Interventions

Transcranial magnetic stimulation OTHER

Repetitive transcranial magnetic stimulation

Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

the First Affiliatted Hospital of Chongqing medical Uiversity

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Spinocerebellar Ataxias

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 1, 2025
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2023.05\~2025.05
• Access Criteria: After obtaining informed consent from the patients and ensuring compliance with ethical principles, this study uses Case Report Forms (CRF) and questionnaires to collect subject information. The CRFs and questionnaires are stored in both paper and electronic databases. Data collection occurs after obtaining patients' informed consent at the time of their participation in the study assessment. Two members of the research team independently enter CRF data into the electronic database, and any discrepancies are reconciled before making changes to the entry. Original paper and electronic data are registered and stored in our department's clinical trial archive cabinet.

Locations

CN (1)