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Deep braIn Stimulation for Tremor TractographIC Versus Traditional (DISTINCT)

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ClinicalTrials.gov Identifier: NCT02491554
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Medtronic Neuromodulation Europe
Information provided by (Responsible Party):
Prof. Dr. Volker Arnd Coenen, University Hospital Freiburg

Brief Summary:

This is a monocentric, randomized, controlled, 2 arms, interventional, observer-blinded feasibility trial.

Patients suffering from essential tremor (ET) will be treated with Deep Brain Stimulation (DBS). For the implantation of the DBS electrodes and the DBS system (Activa INS, Medtronic) patients will randomized either to conventional stereotactic surgery of thalamic/subthalamic region with short anesthesia or to MR-tractography guided stereotactic surgery with target point of the dentato-rubro-thalamic bundle (DRT) in general anesthesia.

Patients will visit the study center at screening, baseline/neurosurgery, six and twelve months after neurosurgery.


Condition or disease Intervention/treatment Phase
Essential Tremor Device: Conventional AC-PC based implantation of ACTIVA INS DBS system Device: MR-tractography guided implantation of ACTIVA INS DBS system Not Applicable

Detailed Description:

In this monocentric, randomized, controlled, 2 arms, interventional, observer-blinded feasibility trial patients suffering from therapy resistant essential tremor (ET) will be treated with Deep Brain Stimulation (DBS).

After screening (e.g. obtaining informed consent, assessment of inclusion/exclusion criteria etc.) patients will be randomized to one of the following groups:

Group 1 (conventional):

Conventional AC-PC based DBS implantation in the thalamic/subthalamic region (Vim-cZI) starting as awake surgery with a brief general anesthesia for stimulator implantation at the end of surgery.

Group 2 (tractographic):

Magnetic resonance (MR)-tractography guided DBS implantation in the dentato-rubro-thalamic bundle (DRT) in general anesthesia

At the baseline/neurosurgery visit Quality of Life (QoL) and other parameters will assessed. Medtronic's Activa INS DBS will be implanted according to randomization. DBS will be started approximately one month after surgery and will be applied as per routine.

Patients will have their routine visits. For this trial data of the (routine) visits six and twelve months after neurosurgery will be collected.

Patients receive DBS after the end of the trial according to local standards.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Actual Study Start Date : August 2015
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Active Comparator: Conventional AC-PC based implantation of ACTIVA INS DBS system
Conventional AC-PC based DBS implantation in the thalamic/subthalamic region (Vim-cZI) starting as awake surgery with a brief general anesthesia for stimulator implantation at the end of surgery.
Device: Conventional AC-PC based implantation of ACTIVA INS DBS system
Conventional AC-PC based implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the thalamic/subthalamic region (Vim-cZI).
Other Name: Medtronic ACTIVA INS Deep Brain Stimulation system

Experimental: MR-tractography guided implantation of ACTIVA INS DBS system
MR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle (DRT) in general anesthesia.
Device: MR-tractography guided implantation of ACTIVA INS DBS system
MR-tractography guided implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the DRT.
Other Name: Medtronic ACTIVA INS Deep Brain Stimulation system




Primary Outcome Measures :
  1. Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline [ Time Frame: Baseline, 6 months after neurosurgery ]
    Tremor reduction defined by the difference in Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) at 6 months after intervention to baseline


Secondary Outcome Measures :
  1. Effective tremor reduction at 12 months after intervention [ Time Frame: Baseline, 12 months after neurosurgery ]
    Effective tremor reduction (an FTMTRS score reduction by 50% compared to baseline is regarded as "response") at 12 months after intervention

  2. Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention [ Time Frame: Baseline, 6 and 12 months after neurosurgery ]
    Tremor reduction will be measured by tremor analysis (an accelerometric examination); Unit: Hertz (Hz)

  3. Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention [ Time Frame: Baseline, 6 and 12 months after neurosurgery ]
    Tremor reduction will be assessed during Electromyography (EMG) by the calculation of total power; Unit: mg², with g=9,81 m/s²

  4. Quality of Life: QUEST, SF-36 [ Time Frame: Baseline, 6 and 12 months after neurosurgery ]
    Qualitiy of Life assessed by Quality of Life Essential Tremor Questionnaire (QUEST) and Short Form (36) Health Survey

  5. Size of VAT [ Time Frame: Day 0 (Day of neurosurgery) ]
    Size of Volume of activated tissue (VAT)

  6. Effective contact position with respect to DRT and AC-PC coordinates [ Time Frame: Day 0 (Day of neurosurgery) ]
    Effective contact position of stimulation electrodes (with respect to the Dentato-rubro-thalamic bundle (DRT) and anterior commissure (AC) - posterior commissure (PC) line (ACPC) coordinaties)

  7. Duration of neurosurgery [ Time Frame: Day 0 (Day of neurosurgery) ]
    Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame)

  8. Changes in BDI [ Time Frame: Baseline, 6 and 12 months after neurosurgery ]
    Psychiatric assessment: changes in Beck's Depression Inventory (BDI)

  9. Assessment of (Serious) Adverse Events related to intervention [ Time Frame: Up to 12 months after neurosurgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged ≥ 25 and ≤ 80 years
  2. Patients with Essential Tremor according to the criteria of the consensus statement of the movement disorders society (Deuschl et al. 1998) are included with a medical treatment resistant and disabling postural and/or intentional tremor.
  3. FTMTRS to be completed within 42 days prior surgery
  4. Stable tremor medication for at least 3 months prior inclusion
  5. Written informed consent

Exclusion Criteria:

  1. Major Depression with suicidal thoughts or suicidal thoughts in history
  2. Dementia (Mattis Dementia Rating Score ≤ 130)
  3. Acute psychosis
  4. Patient incapability
  5. Nursing care at home
  6. Surgical contraindications
  7. Medications that are likely to cause interactions in the opinion of the investigator
  8. Known or persistent abuse of medication, drugs or alcohol
  9. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
  10. Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
  11. Current or planned pregnancy, nursing period

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): NCT02491554


Contacts
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Contact: Volker A Coenen, MD +49 761 270 ext 50630 stereotaxie@uniklinik-freiburg.de
Contact: Peter Reinacher, MD +49 761 270 ext 50680 peter.reinacher@uniklinik-freiburg.de

Locations
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Germany
University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery Recruiting
Freiburg, Germany, 79110
Contact: Volker Coenen, MD    +49 761 270 ext 50630    volker.coenen@uniklinik-freiburg.de   
Contact: Fabian Schubach    +49 761 270 ext 77763    fabian.schubach@uniklinik-freiburg.de   
Principal Investigator: Volker Coenen, MD         
Sub-Investigator: Peter Reinacher, MD         
Sub-Investigator: Bastian Sajonz, MD         
Sub-Investigator: Thomas Prokop, MD         
Sub-Investigator: Michael Trippel, MD         
Sponsors and Collaborators
University Hospital Freiburg
Medtronic Neuromodulation Europe
Investigators
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Principal Investigator: Volker A Coenen, MD University Hospital Freiburg

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Volker Arnd Coenen, Prof. Dr. med., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT02491554     History of Changes
Other Study ID Numbers: P000847
DRKS00008913 ( Registry Identifier: German Clinical Trial Register )
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by Prof. Dr. Volker Arnd Coenen, University Hospital Freiburg:
Deep Brain Stimulation
Essential tremor
DISTINCT
MR-tractography guided DBS implantation
Conventional AC-PC based DBS implantation

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