Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00008913 | Registry Identifier | German Clinical Trial Register |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic Neuromodulation Europe | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional AC-PC based implantation of ACTIVA INS DBS system | Active Comparator | 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 implantation of ACTIVA INS DBS system | Experimental | MR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle (DRT) in general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional AC-PC based implantation of ACTIVA INS DBS system | Device | Conventional AC-PC based implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the thalamic/subthalamic region (Vim-cZI). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 months after neurosurgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 12 months after neurosurgery |
| Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Volker A Coenen, MD | Contact | +49 761 270 | 50630 | stereotaxie@uniklinik-freiburg.de |
| Peter Reinacher, MD | Contact | +49 761 270 | 50680 | peter.reinacher@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Volker A Coenen, MD | University Hospital Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery | Recruiting | Freiburg im Breisgau | 79110 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22886006 | Background | Zappia M, Albanese A, Bruno E, Colosimo C, Filippini G, Martinelli P, Nicoletti A, Quattrocchi G, Abbruzzese G, Berardelli A, Allegra R, Aniello MS, Elia AE, Martino D, Murgia D, Picillo M, Squintani G. Treatment of essential tremor: a systematic review of evidence and recommendations from the Italian Movement Disorders Association. J Neurol. 2013 Mar;260(3):714-40. doi: 10.1007/s00415-012-6628-x. Epub 2012 Aug 11. | |
| 2940473 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MR-tractography guided implantation of ACTIVA INS DBS system | Device | MR-tractography guided implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the DRT. |
|
|
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 | 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 | 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 | Size of Volume of activated tissue (VAT) | Day 0 (Day of neurosurgery) |
| 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) | Day 0 (Day of neurosurgery) |
| Duration of neurosurgery | Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame) | Day 0 (Day of neurosurgery) |
| Changes in BDI | Psychiatric assessment: changes in Beck's Depression Inventory (BDI) | Baseline, 6 and 12 months after neurosurgery |
| Assessment of (Serious) Adverse Events related to intervention | Up to 12 months after neurosurgery |
| Background |
| Koller W, Biary N, Cone S. Disability in essential tremor: effect of treatment. Neurology. 1986 Jul;36(7):1001-4. doi: 10.1212/wnl.36.7.1001. |
| 24324335 | Background | Chopra A, Klassen BT, Stead M. Current clinical application of deep-brain stimulation for essential tremor. Neuropsychiatr Dis Treat. 2013;9:1859-65. doi: 10.2147/NDT.S32342. Epub 2013 Dec 2. |
| 8592222 | Background | Benabid AL, Pollak P, Gao D, Hoffmann D, Limousin P, Gay E, Payen I, Benazzouz A. Chronic electrical stimulation of the ventralis intermedius nucleus of the thalamus as a treatment of movement disorders. J Neurosurg. 1996 Feb;84(2):203-14. doi: 10.3171/jns.1996.84.2.0203. |
| 23036448 | Background | Deistung A, Schafer A, Schweser F, Biedermann U, Turner R, Reichenbach JR. Toward in vivo histology: a comparison of quantitative susceptibility mapping (QSM) with magnitude-, phase-, and R2*-imaging at ultra-high magnetic field strength. Neuroimage. 2013 Jan 15;65:299-314. doi: 10.1016/j.neuroimage.2012.09.055. Epub 2012 Oct 2. |
| 20173566 | Background | Lemaire JJ, Sakka L, Ouchchane L, Caire F, Gabrillargues J, Bonny JM. Anatomy of the human thalamus based on spontaneous contrast and microscopic voxels in high-field magnetic resonance imaging. Neurosurgery. 2010 Mar;66(3 Suppl Operative):161-72. doi: 10.1227/01.NEU.0000365617.41061.A3. |
| 21553318 | Background | Coenen VA, Allert N, Madler B. A role of diffusion tensor imaging fiber tracking in deep brain stimulation surgery: DBS of the dentato-rubro-thalamic tract (drt) for the treatment of therapy-refractory tremor. Acta Neurochir (Wien). 2011 Aug;153(8):1579-85; discussion 1585. doi: 10.1007/s00701-011-1036-z. Epub 2011 May 8. |
| 25161000 | Background | Coenen VA, Allert N, Paus S, Kronenburger M, Urbach H, Madler B. Modulation of the cerebello-thalamo-cortical network in thalamic deep brain stimulation for tremor: a diffusion tensor imaging study. Neurosurgery. 2014 Dec;75(6):657-69; discussion 669-70. doi: 10.1227/NEU.0000000000000540. |
| 21242831 | Background | Coenen VA, Madler B, Schiffbauer H, Urbach H, Allert N. Individual fiber anatomy of the subthalamic region revealed with diffusion tensor imaging: a concept to identify the deep brain stimulation target for tremor suppression. Neurosurgery. 2011 Apr;68(4):1069-75; discussion 1075-6. doi: 10.1227/NEU.0b013e31820a1a20. |
| 25248076 | Background | Torres CV, Manzanares R, Sola RG. Integrating diffusion tensor imaging-based tractography into deep brain stimulation surgery: a review of the literature. Stereotact Funct Neurosurg. 2014;92(5):282-90. doi: 10.1159/000362937. Epub 2014 Sep 18. |
| 22377809 | Background | Klein JC, Barbe MT, Seifried C, Baudrexel S, Runge M, Maarouf M, Gasser T, Hattingen E, Liebig T, Deichmann R, Timmermann L, Weise L, Hilker R. The tremor network targeted by successful VIM deep brain stimulation in humans. Neurology. 2012 Mar 13;78(11):787-95. doi: 10.1212/WNL.0b013e318249f702. Epub 2012 Feb 29. |
| 28007690 | Derived | Sajonz BE, Amtage F, Reinacher PC, Jenkner C, Piroth T, Katzler J, Urbach H, Coenen VA. Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT): Study Protocol of a Randomized Controlled Feasibility Trial. JMIR Res Protoc. 2016 Dec 22;5(4):e244. doi: 10.2196/resprot.6885. |