Clinical trial NCT06904716: The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia
Official title: The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinocerebellar Ataxia
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)
2. Patients with significantly abnormal clinical indicators identified during screening
3. Patients concurrently participating in another clinical study
4. Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders
5. Patients with severe heart disease
6. Patients who are wheelchair users
7. pregnant woman
8. Patients who cannot establish their identity or have limited legal capacity
9. 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.

Primary outcomes:
measure: Scale for the assessment and rating of ataxia
timeFrame: Baseline and one week post-baseline (after treatment)
measure: Resting - state electroencephalogram
timeFrame: baseline and one week post-baseline (after treatment)
measure: Transcranial Magnetic Stimulation - Electroencephalogram（TMS-EEG）
timeFrame: Baseline and one week post-baseline (after treatment)
Secondary outcomes:
measure: The International Cooperative Ataxia Rating Scale (ICARS)
timeFrame: Baseline and one week post-baseline (after treatment)
measure: The Neurological Examination Score for the assessment of Spinocerebellar Ataxias (NESSCA)
timeFrame: Baseline and one week post-baseline (after treatment)
measure: The EQ Visual Analogue Scale
timeFrame: Baseline and one week post-baseline (after treatment)
measure: Gait analysis
timeFrame: Baseline and one week post-baseline (after treatment)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliatted Hospital of Chongqing medical Uiversity
state: Chongqing
Study officials:
References: