Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 219 for:    Ataxia

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
Sponsor:
Information provided by (Responsible Party):
Rubens Gisbert Cury, 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.

Condition or disease Intervention/treatment Phase
Cerebellar Ataxia Device: Transcranial Magnetic Stimulation (TMS) Device: Sham Stimulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Rubens G Cury, MD PhD 55 11 26617877 rubens_cury@usp.br
Contact: Carina C França, MD 55 11 26617877 franca.carina@gmail.com

Locations
Layout table for location information
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Rubens G Cury, MD PhD    55 11 26617877    rubens_cury@usp.br   
Sub-Investigator: Carina C França, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Rubens G Cury, MD PhD University of Sao Paulo General Hospital

Layout table for additonal information
Responsible Party: Rubens Gisbert Cury, Dr Rubens Gisbert Cury, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03213106     History of Changes
Other Study ID Numbers: 1.310.275
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rubens Gisbert Cury, University of Sao Paulo General Hospital:
TMS
Transcranial Magnetic Stimulation
Cerebellar Ataxia

Additional relevant MeSH terms:
Layout table for MeSH terms
Ataxia
Cerebellar Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases