Cerebellar Non-invasive Stimulation in Ataxias
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03213106|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebellar Ataxia||Device: Transcranial Magnetic Stimulation (TMS) Device: Sham Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||5 sessions of active and sham rTMS separated by at least 4 weeks washout.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Cerebellar Transcranial Magnetic Stimulation in Cerebellar Ataxias|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 1, 2017|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Transcranial Magnetic Stimulation (TMS) Stimulation
All patients will receive 5 sessions of active TMS stimulation.
Device: Transcranial Magnetic Stimulation (TMS)
Low frequency (1Hz) transcranial magnetic stimulation aimed to the dentate nucleus contralateral to the most symptomatic side.
Sham Comparator: Sham Stimulation
All patients will receive 5 sessions of active TMS stimulation
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.
- Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA) [ 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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213106
|Contact: Rubens G Cury, MD PhD||55 11 email@example.com|
|Contact: Carina C França, MD||55 11 firstname.lastname@example.org|
|Hospital das Clínicas da Faculdade de Medicina da USP||Recruiting|
|São Paulo, SP, Brazil, 05403000|
|Contact: Rubens G Cury, MD PhD 55 11 26617877 email@example.com|
|Sub-Investigator: Carina C França, MD|
|Principal Investigator:||Rubens G Cury, MD PhD||University of Sao Paulo General Hospital|