Deep braIn Stimulation for Tremor TractographIC Versus Traditional (DISTINCT)

University Hospital Freiburg

Status: Unknown

Conditions: Essential Tremor

Treatments: Device: MR-tractography guided implantation of ACTIVA INS DBS system; Device: Conventional AC-PC based implantation of ACTIVA INS DBS system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02491554

DRKS00008913 (Registry Identifier)

P000847

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Conventional AC-PC based implantation of ACTIVA INS DBS system

Active Comparator group

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.

Treatment:

Device: Conventional AC-PC based implantation of ACTIVA INS DBS system

MR-tractography guided implantation of ACTIVA INS DBS system

Experimental group

Description:

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

Treatment:

Device: MR-tractography guided implantation of ACTIVA INS DBS system