Cerebellar Non-invasive Stimulation in Ataxias

Not Applicable

• Conditions: Cerebellar Ataxia
• Interventions: Device: Transcranial Magnetic Stimulation (TMS); Device: Sham Stimulation

• Registration Number: NCT03213106
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2016-12-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2017-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation (TMS) Stimulation	Transcranial Magnetic Stimulation (TMS)	All patients will receive 5 sessions of active TMS stimulation.
Sham Stimulation	Sham Stimulation	All patients will receive 5 sessions of active TMS stimulation

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)	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)	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.

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da USP; 🇧🇷 São Paulo, SP, Brazil