Back to resultsDeep braIn Stimulation for Tremor TractographIC Versus Traditional (DISTINCT)
Primary Purpose
Essential Tremor
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Conventional AC-PC based implantation of ACTIVA INS DBS system
MR-tractography guided implantation of ACTIVA INS DBS system
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Deep Brain Stimulation, Essential tremor, DISTINCT, MR-tractography guided DBS implantation, Conventional AC-PC based DBS implantation
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged ≥ 25 and ≤ 80 years
- 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.
- FTMTRS to be completed within 42 days prior surgery
- Stable tremor medication for at least 3 months prior inclusion
- Written informed consent
Exclusion Criteria:
- Major Depression with suicidal thoughts or suicidal thoughts in history
- Dementia (Mattis Dementia Rating Score ≤ 130)
- Acute psychosis
- Patient incapability
- Nursing care at home
- Surgical contraindications
- Medications that are likely to cause interactions in the opinion of the investigator
- Known or persistent abuse of medication, drugs or alcohol
- Persons who are in a relationship of dependence/employment with the sponsor or the investigator
- 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;
- Current or planned pregnancy, nursing period
Sites / Locations
- University of Freiburg - Medical Center - Dept. of Stereotactic and Functional NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional AC-PC based implantation of ACTIVA INS DBS system
MR-tractography guided implantation of ACTIVA INS DBS system
Arm Description
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.
MR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle (DRT) in general anesthesia.
Outcomes
Primary Outcome Measures
Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline
Tremor reduction defined by the difference in Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) at 6 months after intervention to baseline
Secondary Outcome Measures
Effective tremor reduction at 12 months after intervention
Effective tremor reduction (an FTMTRS score reduction by 50% compared to baseline is regarded as "response") at 12 months after intervention
Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention
Tremor reduction will be measured by tremor analysis (an accelerometric examination); Unit: Hertz (Hz)
Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention
Tremor reduction will be assessed during Electromyography (EMG) by the calculation of total power; Unit: mg², with g=9,81 m/s²
Quality of Life: QUEST, SF-36
Quality of Life assessed by Quality of Life Essential Tremor Questionnaire (QUEST) and Short Form (36) Health Survey
Size of VAT
Size of Volume of activated tissue (VAT)
Effective contact position with respect to DRT and AC-PC coordinates
Effective contact position of stimulation electrodes (with respect to the Dentato-rubro-thalamic bundle (DRT) and anterior commissure (AC) - posterior commissure (PC) line (ACPC) coordinates)
Duration of neurosurgery
Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame)
Changes in BDI
Psychiatric assessment: changes in Beck's Depression Inventory (BDI)
Assessment of (Serious) Adverse Events related to intervention
Full Information
NCT ID
NCT02491554
First Posted
June 30, 2015
Last Updated
July 20, 2021
Sponsor
University Hospital Freiburg
Collaborators
Medtronic Neuromodulation Europe
1. Study Identification
Unique Protocol Identification Number
NCT02491554
Brief Title
Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Acronym
DISTINCT
Official Title
Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg
Collaborators
Medtronic Neuromodulation Europe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Deep Brain Stimulation, Essential tremor, DISTINCT, MR-tractography guided DBS implantation, Conventional AC-PC based DBS implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional AC-PC based implantation of ACTIVA INS DBS system
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MR-tractography guided implantation of ACTIVA INS DBS system
Arm Type
Experimental
Arm Description
MR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle (DRT) in general anesthesia.
Intervention Type
Device
Intervention Name(s)
Conventional AC-PC based implantation of ACTIVA INS DBS system
Other Intervention Name(s)
Medtronic ACTIVA INS Deep Brain Stimulation system
Intervention Description
Conventional AC-PC based implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the thalamic/subthalamic region (Vim-cZI).
Intervention Type
Device
Intervention Name(s)
MR-tractography guided implantation of ACTIVA INS DBS system
Other Intervention Name(s)
Medtronic ACTIVA INS Deep Brain Stimulation system
Intervention Description
MR-tractography guided implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the DRT.
Primary Outcome Measure Information:
Title
Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline
Description
Tremor reduction defined by the difference in Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) at 6 months after intervention to baseline
Time Frame
Baseline, 6 months after neurosurgery
Secondary Outcome Measure Information:
Title
Effective tremor reduction at 12 months after intervention
Description
Effective tremor reduction (an FTMTRS score reduction by 50% compared to baseline is regarded as "response") at 12 months after intervention
Time Frame
Baseline, 12 months after neurosurgery
Title
Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention
Description
Tremor reduction will be measured by tremor analysis (an accelerometric examination); Unit: Hertz (Hz)
Time Frame
Baseline, 6 and 12 months after neurosurgery
Title
Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention
Description
Tremor reduction will be assessed during Electromyography (EMG) by the calculation of total power; Unit: mg², with g=9,81 m/s²
Time Frame
Baseline, 6 and 12 months after neurosurgery
Title
Quality of Life: QUEST, SF-36
Description
Quality of Life assessed by Quality of Life Essential Tremor Questionnaire (QUEST) and Short Form (36) Health Survey
Time Frame
Baseline, 6 and 12 months after neurosurgery
Title
Size of VAT
Description
Size of Volume of activated tissue (VAT)
Time Frame
Day 0 (Day of neurosurgery)
Title
Effective contact position with respect to DRT and AC-PC coordinates
Description
Effective contact position of stimulation electrodes (with respect to the Dentato-rubro-thalamic bundle (DRT) and anterior commissure (AC) - posterior commissure (PC) line (ACPC) coordinates)
Time Frame
Day 0 (Day of neurosurgery)
Title
Duration of neurosurgery
Description
Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame)
Time Frame
Day 0 (Day of neurosurgery)
Title
Changes in BDI
Description
Psychiatric assessment: changes in Beck's Depression Inventory (BDI)
Time Frame
Baseline, 6 and 12 months after neurosurgery
Title
Assessment of (Serious) Adverse Events related to intervention
Time Frame
Up to 12 months after neurosurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged ≥ 25 and ≤ 80 years
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.
FTMTRS to be completed within 42 days prior surgery
Stable tremor medication for at least 3 months prior inclusion
Written informed consent
Exclusion Criteria:
Major Depression with suicidal thoughts or suicidal thoughts in history
Dementia (Mattis Dementia Rating Score ≤ 130)
Acute psychosis
Patient incapability
Nursing care at home
Surgical contraindications
Medications that are likely to cause interactions in the opinion of the investigator
Known or persistent abuse of medication, drugs or alcohol
Persons who are in a relationship of dependence/employment with the sponsor or the investigator
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;
Current or planned pregnancy, nursing period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Volker A Coenen, MD
Phone
+49 761 270
Ext
50630
Email
stereotaxie@uniklinik-freiburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Reinacher, MD
Phone
+49 761 270
Ext
50680
Email
peter.reinacher@uniklinik-freiburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker A Coenen, MD
Organizational Affiliation
University Hospital Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Coenen, MD
Phone
+49 761 270
Ext
50630
Email
volker.coenen@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Fabian Schubach
Phone
+49 761 270
Ext
77763
Email
fabian.schubach@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Volker Coenen, MD
First Name & Middle Initial & Last Name & Degree
Peter Reinacher, MD
First Name & Middle Initial & Last Name & Degree
Bastian Sajonz, MD
First Name & Middle Initial & Last Name & Degree
Thomas Prokop, MD
First Name & Middle Initial & Last Name & Degree
Michael Trippel, MD
12. IPD Sharing Statement
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Deep braIn Stimulation for Tremor TractographIC Versus Traditional
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