Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

NCT ID: NCT05621200

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2022-12-10

Brief Summary

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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

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Conditions

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Ataxia Spinocerebellar Ataxias Multiple System Atrophy Ataxia With Oculomotor Apraxia CANVAS

Keywords

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transcranial direct current stimulation transcranial alternate current stimulation spinocerebellar ataxia cerebellar ataxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Transcranial direct current stimulation (tDCS)

Single session of anodal tDCS at 2 mA over the cerebellar hemispheres

Group Type ACTIVE_COMPARATOR

Transcranial stimulation over the cerebellar hemispheres

Intervention Type DEVICE

Single session of Transcranial stimulation over the cerebellar hemispheres

Transcranial alternate current stimulation (tDCS)

Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres

Group Type ACTIVE_COMPARATOR

Transcranial stimulation over the cerebellar hemispheres

Intervention Type DEVICE

Single session of Transcranial stimulation over the cerebellar hemispheres

Placebo stimulation (sham)

Single session of sham tDCS over the cerebellar hemispheres

Group Type SHAM_COMPARATOR

Transcranial stimulation over the cerebellar hemispheres

Intervention Type DEVICE

Single session of Transcranial stimulation over the cerebellar hemispheres

Interventions

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Transcranial stimulation over the cerebellar hemispheres

Single session of Transcranial stimulation over the cerebellar hemispheres

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Barbara Borroni

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Borroni, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Spedali Civili di Brescia

Alberto Benussi, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

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ASST Spedali Civili di Brescia

Brescia, BS, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 30135258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27838276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26274840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33950222 (View on PubMed)

Libri I, Cantoni V, Benussi A, Rivolta J, Ferrari C, Fancellu R, Synofzik M, Alberici A, Padovani A, Borroni B. Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial. Cerebellum. 2024 Apr;23(2):570-578. doi: 10.1007/s12311-023-01578-6. Epub 2023 Jun 22.

Reference Type DERIVED
PMID: 37349632 (View on PubMed)

Other Identifiers

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NP4514

Identifier Type: -

Identifier Source: org_study_id