Effects of combined cerebellar tACS-iTBS in individuals with ataxia (EtABeta): a crossover investigation.
Danny Adrian Spampinato, Valentina Pezzopane, Alex Martino Cinnera...
https://pubmed.ncbi.nlm.nih.gov/41877266/Actively Recruiting
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
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
Effects of Cerebellar tACS-iTBS in Ataxia
G
Giacomo Koch, Prof.
V
Valentina Pezzopane, MSc
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I.R.C.C.S. Fondazione Santa Lucia
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive 10 sessions of combined cerebellar transcranial alternating current stimulation (tACS) and intermittent theta burst stimulation (iTBS) coupled with exergaming biofeedback. Sessions occur 5 times per week for two weeks, with stimulation applied to the cerebellum and balance exercises guided by an adaptive video interface.
10 visits (in-person) over 2 weeks
Duration - 2 weeks
Participants receive 10 sessions of sham cerebellar tACS and iTBS coupled with exergaming biofeedback in a crossover design, occurring 5 times per week for two weeks. This serves as a control to compare against the real stimulation sessions.
10 visits (in-person) over 2 weeks
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor