Effects of Cerebellar tACS-iTBS in Ataxia (EtABeta)

I.R.C.C.S. Fondazione Santa Lucia

Status: Enrolling

Conditions: Ataxia

Treatments: Device: Sham (sham iTBS/tACS + exergaming); Device: Real (real iTBS/tACS + exergaming)

Study type: Interventional

Funder types: Other

Identifiers

NCT06420271

80/SL/23

Details and patient eligibility

About

Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.

Full description

Ataxia comprises a heterogeneous group of acquired or inherited disorders primarily involving cerebellar dysfunction, leading to impaired coordination and motor learning. Traditional treatments, including medication and physical therapy, often provide limited symptomatic improvement. Non-invasive brain stimulation (NIBS) techniques have emerged as promising tools for modulating cerebellar activity and enhancing motor function. Transcranial magnetic stimulation (TMS) can influence cortical excitability and plasticity, and studies have shown that high-frequency cerebellar rTMS can improve motor performance in spinocerebellar ataxia. Intermittent theta burst stimulation (iTBS), a patterned form of TMS, has demonstrated benefits in other movement disorders, suggesting potential applicability to ataxia. Transcranial direct current stimulation (tDCS), which modulates neuronal excitability via weak electrical currents, has shown improvements in static and dynamic balance in degenerative cerebellar ataxia. Transcranial alternating current stimulation (tACS) modulates neural oscillations and early studies indicate possible benefits for ataxia symptoms. Recent work has explored combining NIBS modalities to enhance neuromodulatory effects. In preliminary experiments, combined cerebellar tACS and iTBS increased MEP amplitudes more than iTBS alone, with effects lasting up to 30 minutes. These synergistic effects may translate into improved motor performance, coordination, and balance. The present study aims to investigate whether combining real or sham tACS with iTBS produces greater benefits than exergaming biofeedback alone in individuals with ataxia. A cross-over design will be used so that each participant serves as their own control. The primary outcomes will include motor coordination, balance, and cerebello-cortical plasticity. The rationale is that tACS may optimize oscillatory activity while iTBS enhances excitability, thereby jointly promoting neuroplasticity in cerebellar networks. The study will recruit individuals diagnosed with ataxia and assess the therapeutic potential of combined NIBS interventions.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Real tACS + real iTBS + exergaming

Experimental group

Description:

10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks.

Treatment:

Device: Real (real iTBS/tACS + exergaming)

Sham tACS + sham iTBS + exergaming

Placebo Comparator group

Description:

10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks.

Treatment:

Device: Sham (sham iTBS/tACS + exergaming)