Clinical trial NCT05621200: Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ataxia
Spinocerebellar Ataxias
Multiple System Atrophy
Ataxia With Oculomotor Apraxia
CANVAS
Keywords: transcranial direct current stimulation
transcranial alternate current stimulation
spinocerebellar ataxia
cerebellar ataxia
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
Secondary outcomes:
measure: Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in Timed Up and Go Test Duration From Baseline
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in Walking Cadence From Baseline
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in 360° Turn From Baseline
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: BS
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Barbara Borroni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Brescia
name: Alberto Benussi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.