Deep braIn Stimulation for Tremor TractographIC Versus Traditional (DISTINCT)

July 20, 2021 updated by: Prof. Dr. Volker Arnd Coenen, University Hospital Freiburg

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

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 Contact

Study Contact Backup

Study Locations

  • Germany
      • Freiburg, Germany, 79110
        • Recruiting
        • University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery
        • Contact:
        • Contact:
        • 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

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

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Medtronic ACTIVA INS Deep Brain Stimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 months after neurosurgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 months after neurosurgery
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)
Baseline, 6 and 12 months after neurosurgery
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
Baseline, 6 and 12 months after neurosurgery
Quality of Life: QUEST, SF-36
Time Frame: Baseline, 6 and 12 months after neurosurgery
Quality of Life assessed by Quality of Life Essential Tremor Questionnaire (QUEST) and Short Form (36) Health Survey
Baseline, 6 and 12 months after neurosurgery
Size of VAT
Time Frame: Day 0 (Day of neurosurgery)
Size of Volume of activated tissue (VAT)
Day 0 (Day of neurosurgery)
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) coordinates)
Day 0 (Day of neurosurgery)
Duration of neurosurgery
Time Frame: Day 0 (Day of neurosurgery)
Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame)
Day 0 (Day of neurosurgery)
Changes in BDI
Time Frame: Baseline, 6 and 12 months after neurosurgery
Psychiatric assessment: changes in Beck's Depression Inventory (BDI)
Baseline, 6 and 12 months after neurosurgery
Assessment of (Serious) Adverse Events related to intervention
Time Frame: Up to 12 months after neurosurgery
Up to 12 months after neurosurgery

Collaborators and Investigators

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

Sponsor

University Hospital Freiburg

Collaborators

Medtronic Neuromodulation Europe

Investigators

  • Principal Investigator: Volker A Coenen, MD, University Hospital Freiburg

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)

August 1, 2015

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P000847
  • DRKS00008913 (Registry Identifier: German Clinical Trial Register)

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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