Deep braIn Stimulation for Tremor TractographIC Versus Traditional

NCT02491554 | Unknown

• 2 other identifiers: P000847DRKS00008913
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor

Keywords

Deep Brain Stimulation; Essential tremor; DISTINCT; MR-tractography guided DBS implantation; Conventional AC-PC based DBS implantation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Effective tremor reduction 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

  Baseline, 6 and 12 months after neurosurgery

• Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention

  Baseline, 6 and 12 months after neurosurgery

• Quality of Life: QUEST, SF-36

  Baseline, 6 and 12 months after neurosurgery

• Size of VAT

  Day 0 (Day of neurosurgery)

Study Arms (2)

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.

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

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.

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

Interventions

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).

Also known as: Medtronic ACTIVA INS Deep Brain Stimulation system

Conventional AC-PC based implantation of ACTIVA INS DBS system

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.

Also known as: Medtronic ACTIVA INS Deep Brain Stimulation system

MR-tractography guided implantation of ACTIVA INS DBS system

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 25 and ≤ 80 years
• 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.
• FTMTRS to be completed within 42 days prior surgery
• Written informed consent

You may not qualify if:

• Major Depression with suicidal thoughts or suicidal thoughts in history
• Dementia (Mattis Dementia Rating Score ≤ 130)
• Acute psychosis
• Patient incapability
• Nursing care at home
• Surgical contraindications
• Medications that are likely to cause interactions in the opinion of the investigator
• Known or persistent abuse of medication, drugs or alcohol
• Persons who are in a relationship of dependence/employment with the sponsor or the investigator
• 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;
• Current or planned pregnancy, nursing period

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Medtronic Neuromodulation Europe: collaborator

Study Sites (1)

University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery

Freiburg im Breisgau, 79110, Germany

RECRUITING

Related Publications (12)

• 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.

  PMID: 22886006 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.

  PMID: 2940473 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.

  PMID: 24324335 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.

  PMID: 8592222 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.

  PMID: 23036448 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.

  PMID: 20173566 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.

  PMID: 21553318 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.

  PMID: 25161000 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.

  PMID: 21242831 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.

  PMID: 25248076 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.

  PMID: 22377809 BACKGROUND

• 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.

  PMID: 28007690 DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Volker A Coenen, MD

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volker A Coenen, MD

CONTACT

+49 761 270; stereotaxie@uniklinik-freiburg.de

Peter Reinacher, MD

CONTACT

+49 761 270; peter.reinacher@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2015
• Primary Completion: October 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

DE (1)