NCT03341416

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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

October 30, 2017

Last Update Submit

November 13, 2017

Conditions

Cerebellar Ataxia

Keywords

cerebellar ataxiastrokeSpinocerebellar ataxiadeep brain stimulationdentate nucleus

Outcome Measures

Primary Outcomes (1)

  • Primary outcome - change in Scale for the assessment and rating of ataxia - SARA

    To evaluate prospectively the effect of DN-DBS in ataxia. The primary outcome is the change between the Scale for the assessment and rating of ataxia (SARA, ranging from 0-40, higher scores mean more severe ataxia) at baseline and after surgery during the active DBS-ON phase

    change in the SARA score between the baseline versus after surgery during ON-stimulation deep brain stimulation phase. This phase lasts 1 month, so the evaluation will be performed 01 months after the stimulation is turned on.

Secondary Outcomes (2)

  • Secondary outcome - change in tremor score using the Fahn Tolosa Marin Scale

    change in the Fahn Tolosa Marin Scale score between the baseline versus after surgery during ON-stimulation deep brain stimulation phase. This phase lasts 1 month, so the evaluation will be performed 01 months after the stimulation is turned on.

  • Secondary outcome - quality of life

    change in the WHOQOL-bref score between the baseline versus after surgery during ON-stimulation deep brain stimulation phase. This phase lasts 1 month, so the evaluation will be performed 01 months after the stimulation is turned on.

Study Arms (2)

Device - deep brain stimulation ON

EXPERIMENTAL

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

Device: deep brain stimulation on stimulation - active

Device - deep brain stimulation Sham

SHAM COMPARATOR

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

Device: deep brain stimulation off stimulation - sham

Interventions

deep brain stimulation on stimulation - activeDEVICE

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

Device - deep brain stimulation ON
deep brain stimulation off stimulation - shamDEVICE

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

Device - deep brain stimulation Sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Abuse of alcohol, drugs
  • Known psychiatric conditions
  • Contraindications to DBS
  • Heart failure or cardiac disease that contraindicates surgery procedures;
  • Pacemaker or other stimulators implanted active;
  • Positive blood ß-HCG test for women;
  • Other medical conditions demand hospitalization; Participation in other clinical studies at the same time;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rubens Cury

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Cerebellar AtaxiaStrokeSpinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Assistant, Movement Disorders Unit. Principal Investigator. MD, PhD

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 14, 2017

Study Start

September 1, 2017

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)