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

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
• Overall Status: Completed
• CT.gov ID: NCT05621200
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Actual Duration (Months): 22.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ataxia; Spinocerebellar Ataxias; Multiple System Atrophy; Ataxia With Oculomotor Apraxia; CANVAS	Device: Transcranial stimulation over the cerebellar hemispheres	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Interventional Cross-over Study to Evaluate the Efficacy on Motor and Cognitive Performance of Transcranial Alternating Current Stimulation (tACS) in Patients With Neurodegenerative Ataxia
• Actual Study Start Date: Jan 28, 2021
• Actual Primary Completion Date: Dec 10, 2022
• Actual Study Completion Date: Dec 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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

1. 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.

2. 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.

3. 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.

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASST Spedali Civili di Brescia	Brescia	BS	Italy	25123

Sponsors and Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

• Principal Investigator: Barbara Borroni, MD, ASST Spedali Civili di Brescia
• Principal Investigator: Alberto Benussi, MD, Università degli Studi di Brescia

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Barbara Borroni, Professor, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• ClinicalTrials.gov Identifier: NCT05621200
• Other Study ID Numbers: NP4514
• First Posted: Nov 17, 2022
• Last Update Posted: Dec 27, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Barbara Borroni, Professor, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: transcranial direct current stimulation; transcranial alternate current stimulation; spinocerebellar ataxia; cerebellar ataxia
• Additional relevant MeSH terms: Ataxia; Cerebellar Ataxia; Multiple System Atrophy; Shy-Drager Syndrome; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Apraxias; Cogan Syndrome

Study Results

No Results Posted as of Dec 27, 2022