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HIPAA Compliant
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Actively Recruiting

Phase Not Applicable
Age: 8Years - 80Years
All Genders
ID06420271

Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2026-02-17

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ataxia includes various neurological disorders that cause problems with coordination and balance due to cerebellum dysfunction. Traditional treatments often have limited effects, so researchers are exploring non-invasive brain stimulation NIBS methods like transcranial magnetic stimulation TMS, transcranial direct current stimulation tDCS, transcranial alternating current stimulation tACS, and intermittent theta burst stimulation iTBS as possible therapies. This study aims to assess the combined effect of tACS and iTBS on balance in people with ataxia using a cross-over design where each participant serves as their own control. Participants will receive 10 sessions over two weeks of either real or sham 5Hz tACS combined with real or sham iTBS, along with exergaming biofeedback exercises. Stimulation is applied to the cerebellum with specific parameters for each technique, and the exergaming involves balance exercises guided by a computer system. The study compares the combined stimulation plus exergaming against sham stimulation plus exergaming to evaluate added benefits. During the study, participants will be assessed at baseline and after two weeks on measures including motor coordination, balance, and cerebello-cortical plasticity. Tests include the International Cooperative Ataxia Rating Scale ICARS and other scales evaluating health status and postural control. The study also monitors changes in brain excitability. Safety and compliance are tracked throughout, with a total participation period covering both treatment phases and assessments.

CONDITIONS

Brief Title

Effects of Cerebellar tACS-iTBS in Ataxia

Who Can Participate

Age: 8Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings
  • Stable medication regimen for at least four weeks prior to the study
  • Sufficient cognitive ability to understand and comply with study instructions
Not Eligible

You will not qualify if you...

  • History of seizures
  • Severe general impairment or concomitant diseases
  • Intracranial metal implants
  • Cardiac pacemaker
  • Pregnancy status

Research Team

G

Giacomo Koch, Prof.

V

Valentina Pezzopane, MSc

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