NCT05621200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

October 20, 2022

Last Update Submit

December 23, 2022

Conditions

AtaxiaSpinocerebellar AtaxiasMultiple System AtrophyAtaxia With Oculomotor ApraxiaCANVAS

Keywords

transcranial direct current stimulationtranscranial alternate current stimulationspinocerebellar ataxiacerebellar ataxia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline

    Baseline (immediately before the intervention) - Immediately after the intervention

  • Change in Timed Up and Go Test Duration From Baseline

    Baseline (immediately before the intervention) - Immediately after the intervention

  • Change in Walking Cadence From Baseline

    Baseline (immediately before the intervention) - Immediately after the intervention

  • Change in 360° Turn From Baseline

    Baseline (immediately before the intervention) - Immediately after the intervention

Study Arms (3)

Transcranial direct current stimulation (tDCS)

ACTIVE COMPARATOR

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

Device: Transcranial stimulation over the cerebellar hemispheres

Transcranial alternate current stimulation (tDCS)

ACTIVE COMPARATOR

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

Device: Transcranial stimulation over the cerebellar hemispheres

Placebo stimulation (sham)

SHAM COMPARATOR

Single session of sham tDCS over the cerebellar hemispheres

Device: Transcranial stimulation over the cerebellar hemispheres

Interventions

Transcranial stimulation over the cerebellar hemispheresDEVICE

Single session of Transcranial stimulation over the cerebellar hemispheres

Placebo stimulation (sham)Transcranial alternate current stimulation (tDCS)Transcranial direct current stimulation (tDCS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Related Publications (5)

  • 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.

    PMID: 30135258BACKGROUND

  • 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.

    PMID: 27838276BACKGROUND

  • 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.

    PMID: 26274840BACKGROUND

  • 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.

    PMID: 33950222BACKGROUND

  • 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.

    PMID: 37349632DERIVED

MeSH Terms

Conditions

AtaxiaSpinocerebellar AtaxiasMultiple System AtrophySpinocerebellar ataxia, autosomal recessive 1Cerebellar Ataxia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPrimary DysautonomiasAutonomic Nervous System DiseasesBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Officials

  • Barbara Borroni, MD

    ASST Spedali Civili di Brescia

    PRINCIPAL INVESTIGATOR

  • Alberto Benussi, MD

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2022

First Posted

November 17, 2022

Study Start

January 28, 2021

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)