Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for Pallidal Deep Brain Stimulation

November 22, 2018 updated by: Dr. Norbert Kovacs, University of Pecs

Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for the Deep Brain Stimulation Treatment of Primary Generalized or Segmental Dystonia

The aim of the study is to compare the efficacy and the safety profile of the newly introduced interleaving stimulation mode to those of the standard double monopolar stimulation mode during pallidal deep brain stimulation of primary generalized or segmental dystonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

For the treatment of drug-refractory dystonia, bilateral pallidal deep brain stimulation (GPi-DBS) is proven to be an efficient option. On average, 40-55% improvement on dystonia rating scales (DRS) could be achieved according to the results of multicenter trials lasting for years. However, a considerable portion (10-25%) of the patients experience minimal alleviation despite of good electrode placement. These patients can be regarded as non-responders to GPi-DBS defined as having either limited improvement (< 25% on DRS) or worsening. Besides adjusting the amplitude, frequency or pulse-width of stimulation, one can change the electrode configuration from the commonly applied single monopolar stimulation mode (one contact on the electrode is negative) to either double monopolar stimulation (two -usually adjacent- negative contacts on the electrode are stimulated with same amplitude and pulse-width values) or bipolar stimulation mode (one contact on the electrode is positive) in case of unsatisfactory outcomes. Although these techniques had been utilized in multicenter trials, non-responsiveness to GPi-DBS did occur. Recently the investigators have reported in the Movement Disorders that the newly introduced interleaving stimulation mode was superior to single or double monopolar stimulation in four patients who had initially (6-12 months after implantation) limited response to GPi DBS.

Aims of the study:

To systematically compare the efficacy and the side-effect profile of double monopolar stimulation mode to those of interleaving stimulation mode in a prospective, randomized, double-blind, and cross-over study.

Methods:

The investigators would enroll 20-25 patients with drug refractory segmental or generalized primary dystonia undergoing bilateral GPi-DBS implantation within a 2-3 year time frame. The inclusion and exclusion criteria would follow those of the study of Kupsch et al.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Baranya Megye
      • Pécs, Baranya Megye, Hungary, H-7623
        • Department of Neurology, University of Pécs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ages of 7 and 75 years
  • marked disability owing to primary generalized or segmental dystonia, despite optimal pharmacologic treatment
  • disease duration of at least 5 years.

Exclusion Criteria:

  • previous brain surgery;
  • cognitive impairment (< 120 points on the Mattis Dementia Rating Scale)
  • moderate-to-severe depression (> 25 points on the Beck Depression Inventory)
  • marked brain atrophy as detected by magnetic resonance imaging
  • other medical or psychiatric coexisting disorders that could increase the surgical risk or interfere with completion of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Process 1
  • Visit 1: Baseline evaluation (maximum 1 week before operation)
  • Visit 2: Testing of electrodes and subsequent initiation of interleaving stimulation mode (4th postoperative week).
  • Visit 3 Evaluation and cross-over to double-monopolar stimulation mode (16th postoperative week).
  • Visit 4 Final evaluation. (28th postoperative week).
Device: Interleaving stimulation mode (Medtronic)
Interleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)'
Other Names:
  • Medtronic Activa RC Interleaving Stimulation Mode
Device: Double monopolar stimulation mode (Medtronic)
Double monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)'
Other Names:
  • Medtronic Activa RC Double Monopolar Stimulation Mode
Active Comparator: Process 2
  • Visit 1: Baseline evaluation (maximum 1 week before operation)
  • Visit 2: Testing of electrodes and subsequent initiation of double-monopolar stimulation mode (4th postoperative week).
  • Visit 3 Evaluation and cross-over to interleaving stimulation mode (16th postoperative week).
  • Visit 4 Final evaluation. (28th postoperative week).
Device: Interleaving stimulation mode (Medtronic)
Interleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)'
Other Names:
  • Medtronic Activa RC Interleaving Stimulation Mode
Device: Double monopolar stimulation mode (Medtronic)
Double monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)'
Other Names:
  • Medtronic Activa RC Double Monopolar Stimulation Mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in severity of dystonia
Time Frame: 7 months
Differences in severity of dystonia measured by Burke-Fahn-Marsden Dystonia Rating Scale
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment responders after three months deep brain stimulation
Time Frame: 7 months
Differences in number of treatment responders (at least 25% improvement on Burke-Fahn-Marsden Dystonia Rating Scale compared to baseline)
7 months
Health-related quality of life after three months deep brain stimulation
Time Frame: 7 months
Differences in health-related quality of life measured by EQ-5D and SF-36 scales
7 months
Side-effect profile after three months deep brain stimulation
Time Frame: 7 months
Differences in side-effect profile measured by stuctured deep brain stimulation-related side-effect questionnaire
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Principal Investigator: Norbert Kovacs, MD, PhD, Associate professor, Department of Neurology, University of Pecs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

June 7, 2018

Study Completion (Actual)

June 7, 2018

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 22, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 760906

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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