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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Pecs
Sponsor:
Information provided by (Responsible Party):
Dr. Norbert Kovacs, University of Pecs
ClinicalTrials.gov Identifier:
NCT01497639
First received: December 14, 2011
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Primary Dystonia
Device: Interleaving stimulation mode (Medtronic)
Device: Double monopolar stimulation mode (Medtronic)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for the Deep Brain Stimulation Treatment of Primary Generalized or Segmental Dystonia

Resource links provided by NLM:


Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • Differences in severity of dystonia [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Differences in severity of dystonia measured by Burke-Fahn-Marsden Dystonia Rating Scale


Secondary Outcome Measures:
  • Number of treatment responders after three months deep brain stimulation [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Differences in number of treatment responders (at least 25% improvement on Burke-Fahn-Marsden Dystonia Rating Scale compared to baseline)

  • Health-related quality of life after three months deep brain stimulation [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Differences in health-related quality of life measured by EQ-5D and SF-36 scales

  • Side-effect profile after three months deep brain stimulation [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    Differences in side-effect profile measured by stuctured deep brain stimulation-related side-effect questionnaire


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
Other Name: 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
Other Name: 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
Other Name: Medtronic Activa RC Double Monopolar Stimulation Mode

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.

  Eligibility

Ages Eligible for Study:   7 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497639

Contacts
Contact: Norbert Kovacs, MD, PhD +3672535910 kovacsnorbert06@gmail.com

Locations
Hungary
Department of Neurology, University of Pécs Recruiting
Pécs, Baranya Megye, Hungary, H-7623
Contact: Norbert Kovacs, MD, PhD    +3672535910    kovacsnorbert06@gmail.com   
Principal Investigator: Norbert Kovacs, MD, PhD         
Sponsors and Collaborators
University of Pecs
Investigators
Principal Investigator: Norbert Kovacs, MD, PhD Associate professor, Department of Neurology, University of Pecs
  More Information

Publications:

Responsible Party: Dr. Norbert Kovacs, Associate professor, specialist in neurology and movement disorders, Department of Neurology, University of Pecs
ClinicalTrials.gov Identifier: NCT01497639     History of Changes
Other Study ID Numbers: 760906
Study First Received: December 14, 2011
Last Updated: September 20, 2012
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee

Keywords provided by University of Pecs:
dystonia
pallidal stimulation
deep brain stimulation
deep brain stimulation of GPi
GPi
interleaving stimulation

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014