Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

Multiple System Atrophy Clinical Trial

— SCAtACS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621200
• Other study ID #: NP4514
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: December 10, 2022

Study information

• Verified date: December 2022
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apraxias
• Ataxia
• Ataxia With Oculomotor Apraxia
• CANVAS
• Cerebellar Ataxia
• Multiple System Atrophy
• Shy-Drager Syndrome
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

Device:
• Transcranial stimulation over the cerebellar hemispheres
Single session of Transcranial stimulation over the cerebellar hemispheres

Locations

Country	Name	City	State
Italy	ASST Spedali Civili di Brescia	Brescia	BS

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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