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A Clinical Study on the Safety and Efficacy of Novel tTIS Technology Targeting the Cerebellum in the Treatment of Patients with Cerebellar Ataxia

A Clinical Study on the Safety and Efficacy of Novel tTIS Technology Targeting the Cerebellum in the Treatment of Patients with Cerebellar Ataxia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110011
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-09
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Ataxia

Interventions

Intervention group:Electrode placement: Based on individualized finite element head models derived from brain imaging data, the distribution of the temporal interference (TI) electric field in the cer
Stimulation difference frequency: 50 Hz
Stimulation duration: 60 minutes per continuous session
Total treatment duration: 1 week of consecutive treatment.

Sponsors

Department of Neurology, Xuanwu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Disease Diagnosis (meet any one of the following criteria): Multiple System Atrophy Cerebellar Type (MSA-C): Diagnosis meets the criteria outlined in the Movement Disorders 2020 edition. Hereditary Cerebellar Ataxia: Confirmed by genetic testing (e.g., SCA1-3, FRDA, etc.). Immune-Mediated Cerebellar Ataxia: Positive for specific antibodies in serum/cerebrospinal fluid. (2) Absence of other neurodegenerative diseases; (3) Aged 45–75 years, both male and female; (4) Willing to participate in the study and having provided signed informed consent; (5) Ability to fully cooperate with the treatment and complete the 2-month follow-up.

Exclusion criteria

Exclusion criteria: (1) Individuals with severe internal medical diseases, psychiatric disorders, or those lacking legal capacity or with limited legal capacity; (2) Those with significant abnormalities in relevant laboratory tests or examinations (e.g., abnormal blood biochemical tests or electrocardiogram findings); (3) Individuals with intracranial metal foreign bodies, cardiac pacemakers, cardiac stents, or cochlear implants; (4) Patients with intracranial infections, acute-phase cerebral hemorrhage, or significantly increased intracranial pressure; (5) Those with severe hearing or visual impairment that prevents cooperation during examinations; (6) Presence of internal devices or objects such as pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal fragments; (7) Other contraindications for MRI scanning, including foreign bodies in the eyes, skin, or body.

Design outcomes

Primary

MeasureTime frame
Dynamic Gait Analysis;

Secondary

MeasureTime frame
Ataxia Scale;BBS;

Countries

China

Contacts

Public ContactLin Hua

Xuanwu Hospital, Capital Medical University

linhuadoctor@163.com+86 135 2016 3017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026