Effects of Cerebellar tACS-iTBS in Ataxia

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Ataxia
Interventions
DEVICE

Real (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. 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): 1) latero-lateral load shift; 2) antero posterior load shift; 3) omnidirectional displacement (combined latero-lateral and antero-posterior loading).

DEVICE

Sham (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. 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): 1) latero-lateral load shift; 2) antero posterior load shift; 3) omnidirectional displacement (combined latero-lateral and antero-posterior loading).

Trial Locations (1)

00179

RECRUITING

IRCCS Santa Lucia Foundation, Rome

All Listed Sponsors
lead

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

OTHER