Validation of the Implantation of a New Electrode for the Treatment of Dystonia

NCT02509338 | Terminated

• 1 other identifier: 9053
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.

Conditions

Generalized Dystonia; Segmental Dystonia; Tardive Dystonia

Outcome Measures

Primary Outcomes (2)

• Technical feasibility of new electrode implantation

  The feasibility of the implantation is evaluated by stereotaxic frame placement, site of incision, burr hole size and location, technique for insertion, connection with the extension cables to the neurostimulator, measure of the impedances, duration of the surgery, MRI control for lead position, comparison of the artefacts of the leads with the artefacts of the standard electrodes.

  One year

• Safety of new electrode implantation (evaluated by the occurence of side effects)

  The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.

  One year

Secondary Outcomes (1)

• clinical effect of deep brain stimulation using one contact-electrodes (Burke Fahn Marsden's dystonia rating scale and the Toronto Western Spasmodic Torticollis Rating Scale)

  One year

Study Arms (1)

Electrode deep brain stimulation

EXPERIMENTAL

Monocontact electrode deep brain stimulation

Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)

Interventions

Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm) DEVICE

Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia

Electrode deep brain stimulation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age superior to 18 years and inferior to 65 years
• Generalized or segmental isolated dystonia or tardive dystonia
• Unsufficient response to pharmacological treatment (improvement \< 30/% on clinical dystonia scales)
• No comorbidity interfering with general anesthesia, or representing contraindication for neurosurgical procedure or with the follow-up during the trial
• Consent of the patient
• Insurance affiliation
• Follow-up possible for 12 months
• Available insurance for the operated patient

You may not qualify if:

• No possibility for clinical follow-up
• Acquired dystonia except for tardive dystonia
• MRI or generalized anesthesia contraindicated
• Anticoagulant treatment or antiaggregant treatment
• Pregnancy
• Ongoing participation to another clinical trial
• Guardianship or Trusteeship
• Person deprived of liberty

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chru Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Tardive Dyskinesia

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura A CIF, MD, PhD

  CHRU Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 28, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

FR (1)