Cerebellar tACS plus iTBS combined with exercise for ataxia balance
Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients
This test will see if combining cerebellar tACS and iTBS with guided exergaming improves balance in people with ataxia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 80 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06420271 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, Lazio
- IRCCS Santa Lucia Foundation — Rome, Lazio, Italy (Recruiting)
Study contacts
- Study coordinator: Giacomo Koch, Prof.
- Email: g.koch@hsantalucia.it
- Phone: 0651501181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.