NCT03120013

Brief Summary

Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

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

February 6, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 28, 2019

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

April 14, 2017

Results QC Date

May 23, 2018

Last Update Submit

March 1, 2020

Conditions

Ataxia, CerebellarCerebellar AtaxiaSpinocerebellar AtaxiasAtaxia, SpinocerebellarSpinocerebellar Ataxia Type 1Spinocerebellar Ataxia Type 2Spinocerebellar Ataxia 3Spinocerebellar DegenerationsFriedreich AtaxiaAtaxia With Oculomotor ApraxiaMultiple System Atrophy

Keywords

Transcranial direct current stimulationTranscranial magnetic 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 - 2 weeks

  • 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 - 2 weeks

Secondary Outcomes (6)

  • Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline

    Baseline - 2 weeks - 1 month - 3 months

  • Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline

    Baseline - 2 weeks - 1 month - 3 months

  • Change in the 9 Hole Peg Test (9HPT) Score From Baseline

    Baseline - 2 weeks - 1 month - 3 months

  • Change in the 8-Meter Walking Time (8MW) Score From Baseline

    Baseline - 2 weeks - 1 month - 3 months

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

    Baseline - 2 weeks - 1 month - 3 months

  • +1 more secondary outcomes

Study Arms (2)

Real tDCS

EXPERIMENTAL

10 days anodal cerebellar and cathodal spinal tDCS

Device: Anodal cerebellar and cathodal spinal tDCS

Sham tDCS

SHAM COMPARATOR

10 days sham cerebellar and sham spinal tDCS

Device: Sham cerebellar and sham spinal tDCS

Interventions

Anodal cerebellar and cathodal spinal tDCSDEVICE

10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Real tDCS
Sham cerebellar and sham spinal tDCSDEVICE

10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Sham 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)

AO Spedali Civili

Brescia, BS, 25100, Italy

Location

Related Publications (9)

  • 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, 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

  • Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

    PMID: 27372845BACKGROUND

  • Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.

    PMID: 25797650BACKGROUND

  • Miranda PC, Salvador R, Wenger C, Fernandes SR. Computational models of non-invasive brain and spinal cord stimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:6457-6460. doi: 10.1109/EMBC.2016.7592207.

    PMID: 28269725BACKGROUND

  • Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

    PMID: 27866120BACKGROUND

  • Fiocchi S, Ravazzani P, Priori A, Parazzini M. Cerebellar and Spinal Direct Current Stimulation in Children: Computational Modeling of the Induced Electric Field. Front Hum Neurosci. 2016 Oct 17;10:522. doi: 10.3389/fnhum.2016.00522. eCollection 2016.

    PMID: 27799905BACKGROUND

  • van Dun K, Bodranghien F, Manto M, Marien P. Targeting the Cerebellum by Noninvasive Neurostimulation: a Review. Cerebellum. 2017 Jun;16(3):695-741. doi: 10.1007/s12311-016-0840-7.

    PMID: 28032321BACKGROUND

  • 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: 30135258RESULT

MeSH Terms

Conditions

Cerebellar AtaxiaSpinocerebellar AtaxiasMachado-Joseph DiseaseSpinocerebellar DegenerationsFriedreich AtaxiaSpinocerebellar ataxia, autosomal recessive 1Multiple System Atrophy

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMitochondrial DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Results Point of Contact

Title
Prof. Barbara Borroni
Organization
University of Brescia
bborroni@inwind.it
+39 0303995631

Study Officials

  • Barbara Borroni, MD

    Azienda Ospedaliera Spedali Civili, Brescia

    PRINCIPAL INVESTIGATOR

  • Alberto Benussi, MD

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

April 14, 2017

First Posted

April 19, 2017

Study Start

February 6, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 3, 2020

Results First Posted

June 28, 2019

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)