Effects of Cerebellar tACS-iTBS in Ataxia

Not Applicable

Not yet recruiting

• Conditions: Ataxia
• Interventions: Device: Real (real iTBS/tACS + exergaming); Device: Sham (sham iTBS/tACS + exergaming)

• Registration Number: NCT06420271
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-20
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Study Start: 2025-05-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real	Real (real iTBS/tACS + exergaming)	10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks.
Sham	Sham (sham iTBS/tACS + exergaming)	10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks.

Primary Outcome Measures

Name	Time	Method
Changes in the Modified International Cooperative Ataxia Rating Scale (MICARS)	Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)	MICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Score ranges from 0 to 120 where 120 indicates severe ataxia.
Change in the Scale for the Assessment and Rating of Ataxia (SARA)	Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)	SARA is a clinical scale developed to assess a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. Score ranges from 0 to 40 where 40 indicates severe ataxia.

Secondary Outcome Measures

Name	Time	Method
Changes in the Short Form-36 Health Survey (SF-36)	Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)	SF-36 is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Scores range from 0 to 100 for each domain, where 100 indicates a more favorable health-state.
Changes in postural control	Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)	Instrumented postural stability will be assessed using a 75 cm (length x width) static force platform (PlatformBPM 120, Physical Support Italia, Italy). The signals will be amplified and acquired using dedicated software (Physical Gait Software Vv. 2.66, Physical SupportItalia, Italy). The length of the center of pressure (CoP) trajectory (mm) will be measured as indicator of the postural stability. An increase in the length of CoP indicates a severe impairment in postural control.
Changes in cortico-spinal excitability	Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)	Twenty Motor evoked potentials (MEPs) will be collected from left and right primary motor cortex with single pulses of transcranial magnetic stimulation (TMS) set at 1 mV. An increase in the MEPs amplitude indicates an improvement in cortico-spinal activity.
Change in Cerebellar Brain Inibition (CBI)	Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)	CBI will be performed with two Magstim figure-of-eight coils (70 mm diameter), one placed over the primary motor cortex and the other centered over the contralateral cerebellar hemisphere, 3 cm lateral to the Inion with an upward current induced to the brain. For each CBI evaluation, we will record 20 TMS test stimuli (TS) over the M1 that were set at intensity to elicit an MEP ∼1 mV. In half of these trials, selected randomly, a TMS conditioning stimulus (CS) was delivered over the contralateral cerebellar hemisphere 5 ms prior to the TS at an intensity of 120% of the resting motor threshold (RMT). Thus, a total of 20 TS and 20 CS + TS pulses will be administered. CBI will be calculated as the ratio of the mean MEP amplitude in the CS + TS relative to TS. An increase in CBI indicates higher connectivity between the cerebellum and primary motor cortex.