NCT03213106

Brief Summary

Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 3, 2017

Last Update Submit

July 7, 2017

Conditions

Cerebellar Ataxia

Keywords

TMSTranscranial Magnetic StimulationCerebellar Ataxia

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)

    Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.

    Day 1 (baseline), day 5 (after 5th TMS session, active or sham), day 33 (new baseline after TMS wash out) and day 38 (after 10th TMS session, active or sham)

Study Arms (2)

Transcranial Magnetic Stimulation (TMS) Stimulation

EXPERIMENTAL

All patients will receive 5 sessions of active TMS stimulation.

Device: Transcranial Magnetic Stimulation (TMS)

Sham Stimulation

SHAM COMPARATOR

All patients will receive 5 sessions of active TMS stimulation

Device: Sham Stimulation

Interventions

Transcranial Magnetic Stimulation (TMS)DEVICE

Low frequency (1Hz) transcranial magnetic stimulation aimed to the dentate nucleus contralateral to the most symptomatic side.

Transcranial Magnetic Stimulation (TMS) Stimulation
Sham StimulationDEVICE

The stimulation coil will be placed in the same spot as the TMS stimulation, but coil will not be attached to the TMS machine.

Sham Stimulation

Eligibility Criteria

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

You may qualify if:

  • identification of cerebellar ataxia based on neurologic examination
  • no improvement after rehabilitation
  • symptoms onset of at least 6 months

You may not qualify if:

  • Younger than 18 months
  • Pregnant or breastfeeding women
  • Participation in other clinical trials
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (1)

  • Franca C, de Andrade DC, Silva V, Galhardoni R, Barbosa ER, Teixeira MJ, Cury RG. Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial. Parkinsonism Relat Disord. 2020 Nov;80:1-6. doi: 10.1016/j.parkreldis.2020.09.001. Epub 2020 Sep 6.

    PMID: 32920321DERIVED

MeSH Terms

Conditions

Cerebellar Ataxia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Rubens G Cury, MD PhD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubens G Cury, MD PhD

CONTACT

55 11 26617877rubens_cury@usp.br

Carina C França, MD

CONTACT

55 11 26617877franca.carina@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 5 sessions of active and sham rTMS separated by at least 4 weeks washout.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Rubens Gisbert Cury

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 11, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

BR(1)