ClinicalTrials.gov record NCT07743866

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Efficacy and Safety of Transcranial Temporal Interference Stimulation of the Cerebellar Dentate Nucleus Using Individualized Head Modeling in Patients With Spinocerebellar Ataxia Type 3

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 75 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study evaluates non-invasive transcranial temporal interference stimulation (tTIS) aimed at the cerebellar dentate nucleus in people with Spinocerebellar Ataxia Type 3. Participants receive ten 20-minute tTIS sessions using one of three difference frequencies (30 Hz, 40 Hz, or 70 Hz) with individualized MRI-based head modeling to guide electrode placement. The trial uses a sequential, non-randomized, single-masked adaptive design that combines safety and early efficacy data to find an optimal stimulation dose.

What it is studying. The study is testing whether specific tTIS stimulation parameters (difference frequencies of 30, 40, or 70 Hz) can be safely delivered to the cerebellar dentate nucleus in people with SCA3, and aims to identify an optimal biological dose by combining safety and short-term efficacy measures using an adaptive, utility-based dose-finding design.

What the researchers hope to learn. Scientific goals are to evaluate safety measures including dose-limiting toxicities, assess short-term change in ataxia severity (SARA score), and calculate a composite Utility (combining safety and efficacy) to identify the stimulation parameters with the best benefit‑risk profile. The study also collects motor, balance, daily‑living measures and multimodal MRI to inform future research.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Transcranial Temporal Interference Stimulation (tTIS)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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;
  • Pregnant or lactating women, or women of childbearing age not using reliable contraception;
  • Previous neuromodulation treatment (e.g., rTMS or tDCS) within the past year;
  • Skin breakdown or inflammation at the electrode placement site, or known allergy to conductive gel or electrode patch adhesives;
  • Currently participating in other interventional clinical trials, or planning to participate in other trials that might affect the outcome assessment of this study during the study period.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Spinocerebellar ataxia type 3 (SCA3), also known as Machado-Joseph disease, is an autosomal dominant neurodegenerative disorder caused by CAG repeat expansion in the ATXN3 gene. Selective degeneration of neurons in the cerebellar dentate nucleus (DN) leads to abnormal cerebellar outflow circuitry and impaired motor control, resulting in progressive gait ataxia, dysarthria and other motor symptoms. Current treatments are symptomatic only, with no disease-modifying therapies available. Deep brain stimulation targeting the dentate nucleus has shown efficacy but is invasive and associated with significant adverse events. Transcranial temporal interference stimulation (tTIS) enables non-invasive, deep and spatially precise neuromodulation. It has been applied in various neurological and psychiatric disorders with favorable safety and efficacy, demonstrating potential for neuromodulation of deep cerebellar circuits. This phase I/II adaptive dose-finding prospective interventional study evaluates the safety and efficacy of tTIS targeting the cerebellar dentate nucleus in patients with spinocerebellar ataxia type 3. Using MRI-derived individualized head models and real-time neuronavigation, the study employs a utility-based Bayesian optimal interval (U-BOIN) design with three difference frequencies: 30 Hz, 40 Hz, and 70 Hz. Patients are enrolled in sequential cohorts of three, with dose escalation guided by a utility-based approach integrating safety and efficacy data. Each patient receives ten tTIS sessions over two consecutive weeks, with one session daily. Motor function, balance function, activities of daily living, and multimodal magnetic resonance imaging are evaluated before the first treatment session and after the final treatment session.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Before treatment you will have an MRI (3D‑T1) so a personalized head model and real‑time neuronavigation can be made to plan electrode placement. You will receive ten sessions of transcranial temporal interference stimulation (tTIS) targeting the bilateral cerebellar dentate nuclei; each session is described in the record as 20 minutes at 2.0 mA (zero‑to‑peak) with cohort difference frequencies of 30 Hz, 40 Hz, or 70 Hz, and the record contains inconsistent wording about whether sessions are once daily or twice daily over the two‑week period. Motor and balance tests (including the SARA ataxia scale), activities‑of‑daily‑living assessments, and multimodal MRI are done before the first session and after the final session, and safety monitoring for adverse events occurs during and immediately after stimulation.

How the study is structured. This is an interventional (phase I/II) treatment study. Participants are placed into sequential cohorts (non-randomized) of three and receive a planned course of tTIS targeting the bilateral cerebellar dentate nuclei using individualized MRI-derived head models. The trial uses a U-BOIN (utility-based Bayesian optimal interval) adaptive design: safety and efficacy data from each cohort guide subsequent dose (frequency) allocation. The record lists ten 20‑minute treatment sessions; the file contains conflicting scheduling details (one place says one session daily over two weeks, another says twice daily, 5 days per week), so the exact session timing is unclear in the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on spinocerebellar ataxia

Clinical trials30 trials listed for spinocerebellar ataxiaEvery trial the registry lists for spinocerebellar ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in spinocerebellar ataxia researchLatest monthly update: September 2026. Includes: NBP trial result. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 7, 2026 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Study completion
Feb 28, 2027 (estimated)
Target enrollment
24 participants (estimated)
Last updated on registry
Sep 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
First Affiliated Hospital of Fujian Medical University
Principal investigator
Xinyuan Chen, Principal Investigator
First Affiliated Hospital of Fujian Medical University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
enrolment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
contraindicated
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
phase I/II
A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
dose-finding
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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