Cerebellar tACS plus iTBS combined with exercise for ataxia balance
Official title: Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients
Run by LIFE - Research and Care Institute - Santa Lucia IRCCS · NCT06420271 · Data updated 2026-11-12
This test will see if combining cerebellar tACS and iTBS with guided exergaming improves balance in people with ataxia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | LIFE - Research and Care Institute - Santa Lucia IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06420271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed diagnosis of ataxia, stable medication for at least four weeks, and sufficient cognitive ability to follow study instructions are appropriate candidates.
✕Probably not a fit
People with a history of seizures, intracranial metal implants, cardiac pacemakers, severe comorbid illness, or who are pregnant are unlikely to qualify and may not receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls people with clinically confirmed ataxia to receive either real combined cerebellar transcranial alternating current stimulation (tACS) and intermittent theta burst stimulation (iTBS) plus guided exergaming or sham stimulation plus the same exergaming. Sessions pair non-invasive electrical and magnetic cerebellar stimulation with balance-focused exercise, and outcomes include clinical balance measures and neurophysiological markers such as motor-evoked potential (MEP) amplitudes. The design compares immediate and short-term changes between the real and sham groups to determine whether combined neuromodulation produces larger improvements than exergaming alone.
Why it matters
Potential benefit: If successful, the approach could improve balance and coordination in people with ataxia beyond what exercise alone provides.
How similar studies have gone: Preliminary work combining cerebellar tACS and iTBS showed greater increases in MEP amplitudes than iTBS alone, but clinical benefits in ataxia remain preliminary and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings. 2. Stable medication regimen for at least four weeks prior to the study. 3. Sufficient cognitive ability to understand and comply with study instructions. Exclusion Criteria: 1. History of seizures. 2. Severe general impairment or concomitant diseases. 3. Intracranial metal implants. 4. Cardiac pacemaker. 5. Pregnancy status.
Where it's running
-
IRCCS Santa Lucia Foundation
Rome, Lazio, Italy Recruiting
Study contacts
- Study coordinator: Giacomo Koch, Prof.
- Email: g.koch@hsantalucia.it
- Phone: 0651501181
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.