Cerebellar Non-invasive Stimulation in Ataxias
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | SP | Brazil | 05403000 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
- Principal Investigator: Rubens G Cury, MD PhD, University of Sao Paulo General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1.310.275