Cerebellar Non-invasive Stimulation in Ataxias

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Cerebellar Ataxia

Treatments: Device: Transcranial Magnetic Stimulation (TMS); Device: Sham Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03213106

1.310.275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Transcranial Magnetic Stimulation (TMS) Stimulation

Experimental group

Description:

All patients will receive 5 sessions of active TMS stimulation.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Sham Stimulation

Sham Comparator group

Description:

All patients will receive 5 sessions of active TMS stimulation

Treatment:

Device: Sham Stimulation