Essential Tremor Clinical Trial
— DISTINCTOfficial title:
Deep braIn Stimulation for Tremor TractographIC Versus Traditional
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | June 30, 2022 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery | Freiburg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Freiburg | Medtronic Neuromodulation Europe |
Germany,
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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. — View Citation
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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. — View Citation
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. — View Citation
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]. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Tremor reduction measured by tremor analysis at baseline and 6 and 12 months after intervention | Tremor reduction will be measured by tremor analysis (an accelerometric examination); Unit: Hertz (Hz) | Baseline, 6 and 12 months after neurosurgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Size of VAT | Size of Volume of activated tissue (VAT) | Day 0 (Day of neurosurgery) | |
Secondary | 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) | |
Secondary | Duration of neurosurgery | Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame) | Day 0 (Day of neurosurgery) | |
Secondary | Changes in BDI | Psychiatric assessment: changes in Beck's Depression Inventory (BDI) | Baseline, 6 and 12 months after neurosurgery | |
Secondary | Assessment of (Serious) Adverse Events related to intervention | Up to 12 months after neurosurgery |
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