Effects of Cerebellar Transcranial Magnetic Stimulation in Cerebellar Ataxias
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebellar Ataxia
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
- Last Updated
- 8 years ago
Overview
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.
Investigators
Rubens Gisbert Cury
Dr Rubens Gisbert Cury
University of Sao Paulo General Hospital
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
Outcomes
Primary Outcomes
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.