- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341416
Effects of Deep Brain Stimulation of the Dentate Nucleus on Cerebellar Ataxia
Deep Brain Stimulation on Cerebellar Ataxia
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- Recruiting
- Rubens Cury
-
Contact:
- Rubens Cury, MD PhD
- Phone Number: 5511972838184
- Email: rubens_cury@usp.br
-
Contact:
- carina franca, MD
- Phone Number: 1131590293
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 |
bilateral deep brain stimulation reaching the dentate nucleus turned ON - phase active
|
Sham Comparator: 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 |
bilateral deep brain stimulation reaching the dentate nucleus turned OFF - phase sham
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary outcome - change in Scale for the assessment and rating of ataxia - SARA
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary outcome - change in tremor score using the Fahn Tolosa Marin Scale
Time Frame: 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.
|
To evaluate prospectively the effect of DN-DBS on tremor.
The secondary outcome is the change between the Fahn Tolosa Marin Scale (ranging from 0-40, higher scores mean worse tremor) at baseline and after surgery during the active DBS-ON phase
|
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
Time Frame: 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.
|
To evaluate prospectively the effect of DN-DBS on quality of life.
The secondary outcome is the change between the World Health Organization Quality of Life (WHOQOL-bref, 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment, higher scores mean better quality of life) at baseline and after surgery during the active DBS-ON phase
|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102178/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebellar Ataxia
-
IRCCS Eugenio MedeaRecruiting
-
University Hospital, Strasbourg, FranceRecruitingAutosomal Recessive Cerebellar AtaxiaFrance
-
Universidade Federal de PernambucoActive, not recruitingAtaxia, CerebellarBrazil
-
Seoul National University HospitalCompletedAtaxia, Cerebellar | Ataxia, ProgressiveKorea, Republic of
-
Ataxia Study GroupGerman Center for Neurodegenerative Diseases (DZNE)RecruitingLate Onset Sporadic Cerebellar AtaxiaNorway, Austria, Germany, Netherlands, Italy
-
Hospices Civils de LyonRecruitingHealthy Volunteers | Optic AtaxiaFrance
-
University of California, Los AngelesRare Diseases Clinical Research Network; Office of Rare Diseases (ORD)CompletedCerebellar Diseases | Episodic Ataxia SyndromeUnited States, Canada, United Kingdom
-
General Hospital of Chinese Armed Police ForcesUnknownHereditary Cerebellar Ataxia.China
-
Ning Wang, MD., PhD.Recruiting
Clinical Trials on deep brain stimulation on stimulation - active
-
Ruijin HospitalActive, not recruitingMajor Depressive Disorder | Deep Brain StimulationChina
-
University Hospital Inselspital, BerneCompletedMovement Disorder | Urinary Tract DiseaseSwitzerland
-
Parc de Salut MarUnknownAnorexia NervosaSpain
-
University of British ColumbiaCompletedDeep Brain Stimulation | Spasmodic Dysphonia | Laryngeal DystoniaCanada
-
University of FloridaRecruitingParkinson Disease | Deep Brain Stimulation | Apraxia, MotorUnited States
-
Abbott Medical DevicesTerminatedDepressive Disorder, Major | Unipolar DepressionUnited States, Canada, United Kingdom
-
Zhiqi MaoRecruitingParkinson's Disease | Executive Function | Electroencephalogram | Functional Near - Infrared SpectroscopyChina
-
Ali Rezai, MDCompleted
-
University of MinnesotaRecruitingParkinson DiseaseUnited States
-
NewronikaTerminatedParkinson DiseaseItaly