Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

Not Applicable

Completed

• Conditions: Ataxia; Ataxia With Oculomotor Apraxia; Multiple System Atrophy; Spinocerebellar Ataxias; CANVAS
• Interventions: Device: Transcranial stimulation over the cerebellar hemispheres

• Registration Number: NCT05621200
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

The aim of the study is to evaluate the effects on motor and cognitive performance of transcranial alternating current stimulation (tACS) compared to transcranial direct current stimulation (tDCS) and placebo stimulation (sham) in patients with neurodegenerative ataxia to identify a possible rehabilitation protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-17
• Status Verified: 2022-12
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

Exclusion Criteria

• Severe head trauma in the past
• History of seizures
• History of ischemic stroke or hemorrhage
• Pacemaker
• Metal implants in the head/neck region
• Severe comorbidity
• Intake of illegal drugs
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation (tDCS)	Transcranial stimulation over the cerebellar hemispheres	Single session of anodal tDCS at 2 mA over the cerebellar hemispheres
Transcranial alternate current stimulation (tDCS)	Transcranial stimulation over the cerebellar hemispheres	Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres
Placebo stimulation (sham)	Transcranial stimulation over the cerebellar hemispheres	Single session of sham tDCS over the cerebellar hemispheres

Primary Outcome Measures

Name	Time	Method
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline	Baseline (immediately before the intervention) - Immediately after the intervention	International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline	Baseline (immediately before the intervention) - Immediately after the intervention	Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).

Secondary Outcome Measures

Name	Time	Method
Change in Walking Cadence From Baseline	Baseline (immediately before the intervention) - Immediately after the intervention	Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors.
Change in 360° Turn From Baseline	Baseline (immediately before the intervention) - Immediately after the intervention	Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors
Change in Timed Up and Go Test Duration From Baseline	Baseline (immediately before the intervention) - Immediately after the intervention	Time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees, assessed with gait sensors.
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline	Baseline (immediately before the intervention) - Immediately after the intervention	Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.

Trial Locations

Locations (1)

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy