Cerebellar Non-invasive Stimulation in Ataxias

NCT ID: NCT03213106

Last Updated: 2017-07-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Cerebellar Ataxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

5 sessions of active and sham rTMS separated by at least 4 weeks washout.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transcranial Magnetic Stimulation (TMS) Stimulation

All patients will receive 5 sessions of active TMS stimulation.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

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

Sham Stimulation

All patients will receive 5 sessions of active TMS stimulation

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type DEVICE

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

Interventions

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Transcranial Magnetic Stimulation (TMS)

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

Intervention Type DEVICE

Sham Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rubens Gisbert Cury

Dr Rubens Gisbert Cury

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubens G Cury, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rubens G Cury, MD PhD

Role: CONTACT

55 11 26617877

Carina C França, MD

Role: CONTACT

55 11 26617877

Facility Contacts

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Rubens G Cury, MD PhD

Role: primary

55 11 26617877

References

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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.

Reference Type DERIVED
PMID: 32920321 (View on PubMed)

Other Identifiers

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1.310.275

Identifier Type: -

Identifier Source: org_study_id

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