Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia (SCAtACS)

Interventional Cross-over Study to Evaluate the Efficacy on Motor and Cognitive Performance of Transcranial Alternating Current Stimulation (tACS) in Patients With Neurodegenerative Ataxia

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.

Study Overview

• Status: Completed
• Conditions: Ataxia; Multiple System Atrophy; Spinocerebellar Ataxias; Ataxia With Oculomotor Apraxia; CANVAS
• Intervention / Treatment: Device: Transcranial stimulation over the cerebellar hemispheres

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BS
    • Brescia, BS, Italy, 25123
      • ASST Spedali Civili di Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transcranial direct current stimulation (tDCS); Single session of anodal tDCS at 2 mA over the cerebellar hemispheres	Device: Transcranial stimulation over the cerebellar hemispheres; Single session of Transcranial stimulation over the cerebellar hemispheres
Active Comparator: Transcranial alternate current stimulation (tDCS); Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres	Device: Transcranial stimulation over the cerebellar hemispheres; Single session of Transcranial stimulation over the cerebellar hemispheres
Sham Comparator: Placebo stimulation (sham); Single session of sham tDCS over the cerebellar hemispheres	Device: Transcranial stimulation over the cerebellar hemispheres; Single session of Transcranial stimulation over the cerebellar hemispheres

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline	Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.	Baseline (immediately before the intervention) - Immediately after the intervention
Change in Timed Up and Go Test Duration From Baseline	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.	Baseline (immediately before the intervention) - Immediately after the intervention
Change in Walking Cadence From Baseline	Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors.	Baseline (immediately before the intervention) - Immediately after the intervention
Change in 360° Turn From Baseline	Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors	Baseline (immediately before the intervention) - Immediately after the intervention

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Investigators: Principal Investigator: Barbara Borroni, MD, ASST Spedali Civili di Brescia

Publications and helpful links

General Publications

• Benussi A, Dell'Era V, Cantoni V, Bonetta E, Grasso R, Manenti R, Cotelli M, Padovani A, Borroni B. Cerebello-spinal tDCS in ataxia: A randomized, double-blind, sham-controlled, crossover trial. Neurology. 2018 Sep 18;91(12):e1090-e1101. doi: 10.1212/WNL.0000000000006210. Epub 2018 Aug 22.
• Benussi A, Dell'Era V, Cotelli MS, Turla M, Casali C, Padovani A, Borroni B. Long term clinical and neurophysiological effects of cerebellar transcranial direct current stimulation in patients with neurodegenerative ataxia. Brain Stimul. 2017 Mar-Apr;10(2):242-250. doi: 10.1016/j.brs.2016.11.001. Epub 2016 Nov 3.
• Benussi A, Koch G, Cotelli M, Padovani A, Borroni B. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study. Mov Disord. 2015 Oct;30(12):1701-5. doi: 10.1002/mds.26356. Epub 2015 Aug 14.
• Benussi A, Cantoni V, Manes M, Libri I, Dell'Era V, Datta A, Thomas C, Ferrari C, Di Fonzo A, Fancellu R, Grassi M, Brusco A, Alberici A, Borroni B. Motor and cognitive outcomes of cerebello-spinal stimulation in neurodegenerative ataxia. Brain. 2021 Sep 4;144(8):2310-2321. doi: 10.1093/brain/awab157.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; spinocerebellar ataxia; cerebellar ataxia; transcranial alternate current stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Vasculitis; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Cranial Nerve Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Cerebellar Diseases; Vestibulocochlear Nerve Diseases; Ataxia; Multiple System Atrophy; Shy-Drager Syndrome; Apraxias; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Cogan Syndrome
• Other Study ID Numbers: NP4514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No