Frequency-dependent modulation of cerebellar excitability during the application of non-invasive alternating current stimulation.
Danny Spampinato, Esin Avci, John Rothwell...
https://pubmed.ncbi.nlm.nih.gov/33482375Actively 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
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
You will not qualify if you...
- History of seizures
- Severe general impairment or concomitant diseases
- Intracranial metal implants
- Cardiac pacemaker
- Pregnancy status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Treatment
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
Trial Site Locations
Total: 1 location
1
IRCCS Santa Lucia Foundation
Rome, Lazio, Italy, 00179
Actively Recruiting
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Research Team
G
Giacomo Koch, Prof.
V
Valentina Pezzopane, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial.
Ilenia Libri, Valentina Cantoni, Alberto Benussi...
https://pubmed.ncbi.nlm.nih.gov/37349632Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation.
Andrea Guerra, Antonio Suppa, Matteo Bologna...
https://pubmed.ncbi.nlm.nih.gov/29615367Efficacy and safety of noninvasive brain stimulation for patients with cerebellar ataxia: a systematic review and meta-analysis of randomized controlled trials.
Cheng Gong, Yi Long, Xu-Miao Peng...
https://pubmed.ncbi.nlm.nih.gov/37460852Effects 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