Clinical trial NCT02491554: Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Official title: Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Tremor
Keywords: Deep Brain Stimulation
Essential tremor
DISTINCT
MR-tractography guided DBS implantation
Conventional AC-PC based DBS implantation
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Medtronic Neuromodulation Europe
First posted: 2015-07-08
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline
timeFrame: Baseline, 6 months after neurosurgery
Secondary outcomes:
measure: Effective tremor reduction at 12 months after intervention
timeFrame: Baseline, 12 months after neurosurgery
measure: Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention
timeFrame: Baseline, 6 and 12 months after neurosurgery
measure: Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention
timeFrame: Baseline, 6 and 12 months after neurosurgery
measure: Quality of Life: QUEST, SF-36
timeFrame: Baseline, 6 and 12 months after neurosurgery
measure: Size of VAT
timeFrame: Day 0 (Day of neurosurgery)
measure: Effective contact position with respect to DRT and AC-PC coordinates
timeFrame: Day 0 (Day of neurosurgery)
measure: Duration of neurosurgery
timeFrame: Day 0 (Day of neurosurgery)
measure: Changes in BDI
timeFrame: Baseline, 6 and 12 months after neurosurgery
measure: Assessment of (Serious) Adverse Events related to intervention
timeFrame: Up to 12 months after neurosurgery
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery
Study officials:
affiliation: University Hospital Freiburg
name: Volker A Coenen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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