NCT03341416

Effects of Deep Brain Stimulation of the Dentate Nucleus on Cerebellar Ataxia

Deep Brain Stimulation on Cerebellar Ataxia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. The hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients and in these patients, chronic cerebellar stimulation through deep brain stimulation could be a therapeutic option. The rationale is to stimulate the dentate nucleus of the cerebellum in order to balance the functional asymmetry observed between both motor cortices after chronic cerebellar lesions.

Detailed description

Ten patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. The initial focus is vascular and spinal cerebellar ataxias. The participants will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, the 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, the participants 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. The good responders, i.e., with over than 30% of improvement after the active section will be eligible to bilateral dentate nucleus DBS. After that, again, a cross-over double blind on-off stimulation will be performed. Each period (on or 0ff-stimulation) will last 4 weeks.

Conditions

• Cerebellar Ataxia

Interventions

Type	Name	Description
DEVICE	deep brain stimulation on stimulation - active	bilateral deep brain stimulation reaching the dentate nucleus turned ON - phase active
DEVICE	deep brain stimulation off stimulation - sham	bilateral deep brain stimulation reaching the dentate nucleus turned OFF - phase sham

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-07-01
• Completion: 2019-01-01
• First posted: 2017-11-14
• Last updated: 2017-11-17

Locations

1 site across 1 country: Brazil