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Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

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ClinicalTrials.gov Identifier: NCT02685280
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

From 1999 onwards, Deep Brain Stimulation [DBS] has been proposed as an alternative to capsulotomy in refractory cases of Obsessive-Compulsive Disorder [OCD]. More recently, several studies with DBS in patients with major depression have been initiated. In Belgium, there is currently a reimbursement for devices for DBS for OCD, but not for rechargeable neurostimulators, in these OCD patients.

Although rechargeable neurostimulators are widely used in spinal cord stimulation for pain and DBS for movement disorders, they have not yet been used in DBS for psychiatric disorders population. Several possible problems might arise with the use of rechargeable neurostimulators in this highly specific population.

In this prospective study with a before-after design, we would like to determine if the use of rechargeable neurostimulators is effective, applicable and safe and capable of diminishing the need for neurostimulator replacement procedures.


Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorder Depression Device: Medtronic Restore Advanced 37713 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study Regarding the Implantation and Use of Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders (Either Obsessive-compulsive Disorder or Major Depression)
Study Start Date : October 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DBS for psychiatric disorders patients
Patients on deep brain stimulation for either obsessive-compulsive disorder or major depression, undergoing rechargeable neurostimulator implantation as intervention
Device: Medtronic Restore Advanced 37713
Rechargeable neurostimulators are implanted when the non-rechargeable neurostimulators are end-of-life.
Other Names:
  • Medtronic Restore 37711
  • Medtronic Activa RC 37612




Primary Outcome Measures :
  1. Change in Y-BOCS (for OCD) [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in mean Yale‐Brown Obsessive Compulsive Scale (Y‐BOCS). Mean Y-BOCS during the first 2 years after intervention minus mean Y-BOCS during the last 2 years before intervention.

  2. Change in HAM-D (for MD) [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in Hamilton Depression Rating Scale (HAM‐D). Mean HAM-D during the first 2 years after intervention minus mean HAM-D during the last 2 years before intervention.


Secondary Outcome Measures :
  1. Change in HAM-D (for OCD) [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in Hamilton Depression Rating Scale (HAM‐D). Mean HAM-D during the first 2 years after intervention minus mean HAM-D during the last 2 years before intervention.

  2. Change in BDI [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in Beck Depression Inventory (BDI). Mean BDI during the first 2 years after intervention minus mean BDI during the last 2 years before intervention.

  3. Change in GAF [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in Global Assessment of Functioning (GAF). Mean GAF during the first 2 years after intervention minus mean GAF during the last 2 years before intervention.

  4. Change in Stimulation Amplitude [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in Stimulation amplitude as measured in volt. Mean stimulation amplitude during the first 2 years after intervention minus mean stimulation amplitude during the last 2 years before intervention.

  5. Change in Stimulation Frequency [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in Stimulation frequency as measured in hertz Mean stimulation frequency during the first 2 years after intervention minus mean stimulation frequency during the last 2 years before intervention

  6. Change in Pulse Width [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Stimulation pulse width as measured in seconds. Mean stimulation pulse width during the first 2 years after intervention minus mean stimulation pulse width during the last 2 years before intervention.

  7. Change in Contact Configuration [ Time Frame: from 2 years before intervention until 2 years after intervention ]

    Change in stimulation contact configuration as expressed in fraction of patients using a certain contact point as anode or cathode.

    Fraction of patients using a certain contact point as cathode or anode during the first 2 years after intervention minus fraction of patients using a certain contact point as cathode or anode during the last 2 years before intervention.


  8. Change in frequency of outpatient clinic contacts at the Psychiatry department [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in frequency of outpatient clinic contacts at the Psychiatry department. Frequency of outpatient clinic contacts at the Psychiatry department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Psychiatry department during the last 2 years before intervention.

  9. Change in fraction of hospitalized days at the Psychiatry department [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in fraction of hospitalized days at the Psychiatry department. Fraction of hospitalized days at the Psychiatry department during the first 2 years after intervention minus fraction of hospitalized days at the Psychiatry department during the last 2 years before intervention.

  10. Change in frequency of outpatient clinic contacts at the Neurosurgery department [ Time Frame: from 2 years before intervention until 2 years after intervention ]

    Change in frequency of outpatient clinic contacts at the Neurosurgery department.

    Frequency of outpatient clinic contacts at the Neurosurgery department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Neurosurgery department during the last 2 years before intervention.


  11. Change in fraction of hospitalized days at the Neurosurgery department [ Time Frame: from 2 years before intervention until 2 years after intervention ]
    Change in fraction of hospitalized days at the Neurosurgery department. Fraction of hospitalized days at the Neurosurgery department during the first 2 years after intervention minus fraction of hospitalized days at the Neurosurgery department during the last 2 years before intervention.

  12. Change in frequency of DBS-related surgical procedures [ Time Frame: from initial electrode implantation through study completion (on average approximately 5 years) ]
    Change in frequency of neurosurgical procedures related to the DBS system. Frequency of neurosurgical procedures related to the DBS system after intervention minus frequency of neurosurgical procedures related to the DBS system before intervention.

  13. Adverse events [ Time Frame: from initial electrode implantation through study completion (on average approximately 5 years) ]
    Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DBS for OCD / DBS for MD patients, AND
  • experiencing a beneficial effect of DBS on the psychiatric symptoms, AND
  • needing at least 1 IPG replacement per 18 months, AND
  • in the possibility to give informed consent for this study

Exclusion Criteria:

  • anyone not meeting all the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685280


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Medtronic
Investigators
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Principal Investigator: Bart Nuttin, MD, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02685280     History of Changes
Other Study ID Numbers: S50760
B32220072682 ( Other Identifier: Belgian national government )
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
rechargeable neurostimulators
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Personality Disorders
Anxiety Disorders