Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008913

Trial Description

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Title

Deep braIn Stimulation for Tremor TractographIC Versus Traditional

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Trial Acronym

DISTINCT

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008913
  •   2015/07/13
  •   2015/06/30
  •   yes
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Secondary IDs

  •   NCT02491554  (ClinicalTrials.gov)
  •   P000847  (University Hospital Freiburg)
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Health Condition or Problem studied

  •   Essential Tremor
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Interventions/Observational Groups

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

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline; time frame: Baseline, 6 months after neurosurgery; Tremor reduction defined by the difference in Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) at 6 months after intervention to baseline

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Secondary Outcome

- Effective tremor reduction at 12 months after intervention; time frame: Baseline, 12 months after neurosurgery; Effective tremor reduction (an FTMTRS score reduction by 50% compared to baseline is regarded as "response") at 12 months after intervention
- Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention; time frame: Baseline, 6 and 12 months after neurosurgery; Tremor reduction will be measured by tremor analysis (an accelerometric examination); Unit: Hertz (Hz)
- Tremor reduction measured by calculation of total power at baseline and 6 and 12 months after intervention; time frame: Baseline, 6 and 12 months after neurosurgery; Tremor reduction will be assessed during Electromyography (EMG) by the calculation of total power; Unit: mg², with g=9,81 m/s²
- Quality of Life: QUEST, SF-36; time frame: Baseline, 6 and 12 months after neurosurgery; Qualitiy of Life assessed by Quality of Life Essential Tremor Questionnaire (QUEST) and Short Form (36) Health Survey
- Size of VAT; time frame: Day 0 (Day of neurosurgery); Size of Volume of activated tissue (VAT)
- Effective contact position with respect to DRT and AC-PC coordinates; time frame: Day 0 (Day of neurosurgery); Effective contact position of stimulation electrodes (with respect to the Dentato-rubro-thalamic bundle (DRT) and anterior commissure (AC) - posterior commissure (PC) line (ACPC) coordinaties)
- Duration of neurosurgery; time frame: Day 0 (Day of neurosurgery); Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame)
- Changes in BDI; time frame: Baseline, 6 and 12 months after neurosurgery; Psychiatric assessment: changes in Beck's Depression Inventory (BDI)
- Assessment of (Serious) Adverse Events related to intervention; time frame: Up to 12 months after neurosurgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2015/07/31
  •   24
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   80   Years
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Additional 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

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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

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Addresses

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    • University Hospital Freiburg
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    • Medtronic Neuromodulation Europe
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    • University Hospital Freiburg
    • Volker A Coenen, MD 
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    • Volker A Coenen, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

  •   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. Review. Erratum in: J Neurol. 2013 Mar;260(3):741. Abbruzzese, Giovanni [added]; Berardelli, Alfredo [added]; Allegra, Roberta [added]; Aniello, Maria Stella [added]; Elia, Antonio E [added]; Martino, Davide [added]; Murgia, Daniela [added]; Picillo, Marina [added]; Squintani, Giovanna [added].; 22886006
  •   Koller W, Biary N, Cone S. Disability in essential tremor: effect of treatment. Neurology. 1986 Jul;36(7):1001-4.; 2940473
  •   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. Review.; 24324335
  •   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.; 8592222
  •   Deistung A, Schäfer 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.; 23036448
  •   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.; 20173566
  •   Coenen VA, Allert N, Mädler 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.; 21553318
  •   Coenen VA, Allert N, Paus S, Kronenbürger M, Urbach H, Mädler 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.; 25161000
  •   Coenen VA, Mädler 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. Erratum in: Neurosurgery. 2011 Jun;68(6):E1780-1.; 21242831
  •   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. Review.; 25248076
  •   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.; 22377809
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
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  •   2015/07/09
* This entry means the parameter is not applicable or has not been set.