Not Yet RecruitingNot Applicable

Optimizing Parameters of Transcranial Temporal Interference Stimulation for Spinocerebellar Ataxia Type 3

China24 participantsStarted 2026-08-07

Plain-language summary

The purpose of this research study is to identify the optimal biological dose for tTIS that targets DN in SCA3 while achieving the best possible balance between therapeutic efficacy and safety.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A physician-diagnosed SCA3 according to diagnostic criteria, with definite clinical symptoms and confirmed genetic testing;
. Age 18-75 years;
. Baseline total score of SARA: 8-30 points (inclusive); SARA gait function subscore: 2-6 points (inclusive);
. Willing to participate and provide informed consent;
. Have a reliable caregiver available;
. No severe cognitive impairment that would preclude reliable reporting of adverse events or efficacy during treatment.

Exclusion criteria

. History of seizures or convulsions, or a seizure within 6 months prior to enrolment;
. History of severe traumatic brain injury or intracranial neurosurgery;
. Presence of cardiac pacemakers, cochlear implants, intracranial implanted electronic devices, or other MRI-contraindicated ferromagnetic implants;
. Severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score ≤ 9) or severe visual, auditory, or speech dysfunction preventing cooperation with scale assessments and study procedures;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: Incidence of Dose-Limiting Toxicity (DLT)

Timeframe: At any point during or immediately following intervention on day of tTIS application

Efficacy: To assess the proportion of patients with SARA improvement (decrease) of at least 1.5 from baseline after 5 days

Timeframe: Baseline and within 24 hours after completing the 5-day tTIS treatment

Comprehensive Benefit-Risk: Utility

Timeframe: Within 24 hours after completing the 5-day tTIS treatment

Trial details

NCT IDNCT07743866

SponsorFirst Affiliated Hospital of Fujian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Xin-Yuan Chen

+86 15005065282 fychenxinyuan@fjmu.edu.cn

View on ClinicalTrials.gov More Spinocerebellar Ataxia Type 3 trials