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Cerebellar Non-invasive Stimulation in Ataxias

Primary Purpose

Cerebellar Ataxia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sham Stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia focused on measuring TMS, Transcranial Magnetic Stimulation, Cerebellar Ataxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da USPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation (TMS) Stimulation

Sham Stimulation

Arm Description

All patients will receive 5 sessions of active TMS stimulation.

All patients will receive 5 sessions of active TMS stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2017
Last Updated
July 7, 2017
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03213106
Brief Title
Cerebellar Non-invasive Stimulation in Ataxias
Official Title
Effects of Cerebellar Transcranial Magnetic Stimulation in Cerebellar Ataxias
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Thirty patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. Patients will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, participants will be randomly assigned to 5 active or 5 placebo sessions of 1Hz TMS over the located area. After the first 5 sessions and a period of at least 4 weeks washout, patients will cross over and receive other 5 sessions, active or sham. Clinical and video evaluations will be conducted before and after active and sham cluster of sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia
Keywords
TMS, Transcranial Magnetic Stimulation, Cerebellar Ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
5 sessions of active and sham rTMS separated by at least 4 weeks washout.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation (TMS) Stimulation
Arm Type
Experimental
Arm Description
All patients will receive 5 sessions of active TMS stimulation.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
All patients will receive 5 sessions of active TMS stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
Low frequency (1Hz) transcranial magnetic stimulation aimed to the dentate nucleus contralateral to the most symptomatic side.
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
The stimulation coil will be placed in the same spot as the TMS stimulation, but coil will not be attached to the TMS machine.
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: identification of cerebellar ataxia based on neurologic examination no improvement after rehabilitation symptoms onset of at least 6 months Exclusion Criteria: Younger than 18 months Pregnant or breastfeeding women Participation in other clinical trials Epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens G Cury, MD PhD
Phone
55 11 26617877
Email
rubens_cury@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Carina C França, MD
Phone
55 11 26617877
Email
franca.carina@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens G Cury, MD PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens G Cury, MD PhD
Phone
55 11 26617877
Email
rubens_cury@usp.br
First Name & Middle Initial & Last Name & Degree
Carina C França, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32920321
Citation
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.
Results Reference
derived

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Cerebellar Non-invasive Stimulation in Ataxias

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