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

NCT ID: NCT03341416

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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

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Cerebellar Ataxia

Keywords

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cerebellar ataxia stroke Spinocerebellar ataxia deep brain stimulation dentate nucleus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

After surgery patients will undergo a first washout period intended to allow their ataxia return to baseline (preoperative levels), thus avoiding post surgery effects bias.

Phase 1: Participants will be randomized to either ON or OFF stimulation. The assigned stimulation will be performed for one week.

Phase 2: Open label phase. All patients are in the ON stimulation condition and will be followed for 6 months.

Duration:

Phase 1 will last from one to 2 months and phase 2 will last six months.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Device - deep brain stimulation ON

Intervention type: device (deep brain stimulation of the dentate nucleus in cerebellum). The intervention is a device called deep brain stimulation bilaterally placed in the sub thalamic nucleus.

The stimulation will remained turned ON during 3 months - phase 1 - blinded and continuous during the open-label phase

Group Type EXPERIMENTAL

deep brain stimulation on stimulation - active

Intervention Type DEVICE

bilateral deep brain stimulation reaching the dentate nucleus turned ON - phase active

Device - deep brain stimulation Sham

Sham stimulation: device (deep brain stimulation of the dentate nucleus in cerebellum). Intervention type: device (deep brain stimulation of the dentate nucleus in cerebellum). The intervention is a device called deep brain stimulation bilaterally placed in the sub thalamic nucleus.

During the sham stimulation the intervention will remained turned OFF during 3 months

Group Type SHAM_COMPARATOR

deep brain stimulation off stimulation - sham

Intervention Type DEVICE

bilateral deep brain stimulation reaching the dentate nucleus turned OFF - phase sham

Interventions

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deep brain stimulation on stimulation - active

bilateral deep brain stimulation reaching the dentate nucleus turned ON - phase active

Intervention Type DEVICE

deep brain stimulation off stimulation - sham

bilateral deep brain stimulation reaching the dentate nucleus turned OFF - phase sham

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with diagnosis of chronic cerebellar ataxia (\> 6 months);
2. Age ≥18 years;
3. Be able to understand study protocol;
4. Signed, written informed consent (approved by the Institutional Ethics Committee) obtained prior to any study procedure;
5. Refractory symptoms response to first, second and third line pharmacological treatment;
6. Daily living activities impaired because the ataxia;
7. Be able to undergo surgery procedures.

Exclusion Criteria

1. Abuse of alcohol, drugs
2. Known psychiatric conditions
3. Contraindications to DBS
4. Heart failure or cardiac disease that contraindicates surgery procedures;
5. Pacemaker or other stimulators implanted active;
6. Positive blood ß-HCG test for women;
7. Other medical conditions demand hospitalization; Participation in other clinical studies at the same time;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rubens Gisbert Cury

Medical Assistant, Movement Disorders Unit. Principal Investigator. MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rubens Cury

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Rubens Cury, MD PhD

Role: primary

carina franca, MD

Role: backup

Other Identifiers

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102178/2015

Identifier Type: -

Identifier Source: org_study_id