RecruitingNot ApplicableNCT06420271

Effects of Cerebellar tACS-iTBS in Ataxia

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

Sponsor

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

Enrollment

30 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ataxia

Summary

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.

Eligibility

Min Age: 8 YearsMax Age: 80 Years

Inclusion Criteria3

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.

Exclusion Criteria5

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

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Interventions

DEVICEReal (real iTBS/tACS + exergaming)

Stimulation will be applied to the cerebellum. The tACS session duration will be 190 seconds with a frequency of 5 Hz coupled with iTBS (coil positioned tangentially with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading).

DEVICESham (sham iTBS/tACS + exergaming)

Stimulation will be applied to the cerebellum. The tACS session duration will be 10 seconds with a frequency of 5 Hz coupled with sham iTBS (coil positioned perpendicularly with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading).