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Deep braIn Stimulation for Tremor TractographIC Versus Traditional

NCT02491554 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-07-28

No results posted yet for this study

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.

Conditions

Interventions

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).

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.

Sponsors & Collaborators

  • Medtronic Neuromodulation Europe

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Volker A Coenen, MD · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-10-31
Completion
2022-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491554 on ClinicalTrials.gov