Essential TremorDISTINCTNCT02491554
Deep braIn Stimulation for Tremor TractographIC Versus Traditional
A study testing Conventional AC-PC based implantation of ACTIVA INS DBS system and MR-tractography guided implantation of ACTIVA INS DBS system in people with Essential Tremor, run by University Hospital Freiburg at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Conventional AC-PC based implantation of ACTIVA INS DBS system and MR-tractography guided implantation of ACTIVA INS DBS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Stable tremor medication for at least 3 months prior inclusion
- Written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery
Freiburg im Breisgau, 79110
Volker Coenen, MD, +49 761 270 ext. 50630, volker.coenen@uniklinik-freiburg.de
Fabian Schubach, +49 761 270 ext. 77763, fabian.schubach@uniklinik-freiburg.de
About this study
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.
Read the detailed description
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.
- Conditions
- Essential Tremor
- Being tested
- Conventional AC-PC based implantation of ACTIVA INS DBS system, MR-tractography guided implantation of ACTIVA INS DBS system
- Keywords
- Deep Brain Stimulation, Essential tremor, DISTINCT, MR-tractography guided DBS implantation, Conventional AC-PC based DBS implantation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional AC-PC based implantation of ACTIVA INS DBS systemDevice
Also called Medtronic ACTIVA INS Deep Brain Stimulation system
Conventional AC-PC based implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the thalamic/subthalamic region (Vim-cZI).
MR-tractography guided implantation of ACTIVA INS DBS systemDevice
Also called Medtronic ACTIVA INS Deep Brain Stimulation system
MR-tractography guided implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the DRT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MR-tractography guided implantation of ACTIVA INS DBS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months after neurosurgery
Secondary outcomes (9)
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
Measured: Baseline, 12 months after neurosurgery
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)
Measured: 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
Measured: 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
Measured: Baseline, 6 and 12 months after neurosurgery
Size of VAT
Size of Volume of activated tissue (VAT)
Measured: 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)
Measured: Day 0 (Day of neurosurgery)
Duration of neurosurgery
Duration of neurosurgery (time points of mounting frame, start surgery, stop surgery (= dismounting frame)
Measured: Day 0 (Day of neurosurgery)
Changes in BDI
Psychiatric assessment: changes in Beck's Depression Inventory (BDI)
Measured: Baseline, 6 and 12 months after neurosurgery
Assessment of (Serious) Adverse Events related to intervention
Measured: Up to 12 months after neurosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Neuromodulation Europe
- Responsible party
- Principal investigator, Prof. Dr. Volker Arnd Coenen, University Hospital Freiburg
- Investigators
- Volker A Coenen, MD, Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491554
- Sponsor's protocol ID
- P000847
- Other IDs
- DRKS00008913
- Acronym
- DISTINCT
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2015
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22886006Koller 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.
PubMed 2940473Chopra 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.
PubMed 24324335Benabid 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.
PubMed 8592222Deistung 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.
PubMed 23036448Lemaire 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.
PubMed 20173566Coenen 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.
PubMed 21553318Coenen 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.
PubMed 25161000Coenen 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.
PubMed 21242831Torres 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.
PubMed 25248076Klein 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.
PubMed 22377809Sajonz 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.
PubMed 28007690
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep braIn Stimulation for Tremor TractographIC Versus Traditional
- ClinicalTrials.gov ID
- NCT02491554
- Acronym / sponsor ID
- DISTINCT / P000847
- Conditions
- Essential Tremor
- Keywords
- Deep Brain Stimulation, Essential tremor, DISTINCT, MR-tractography guided DBS implantation, Conventional AC-PC based DBS implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Medtronic Neuromodulation Europe
- Study start
- Aug 2015 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional AC-PC based implantation of ACTIVA INS DBS system | Active comparator | Device: Conventional AC-PC based implantation of ACTIVA INS DBS systemConventional 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 | Device: MR-tractography guided implantation of ACTIVA INS DBS systemMR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle (DRT) in general anesthesia. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Stable tremor medication for at least 3 months prior inclusion
- Written informed consent
Key exclusion criteria (11 listed)
- Major Depression with suicidal thoughts or suicidal thoughts in history
- Dementia (Mattis Dementia Rating Score ≤ 130)
- Acute psychosis
- Patient incapability
- Nursing care at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional AC-PC based implantation of ACTIVA INS DBS systemAlso: Medtronic ACTIVA INS Deep Brain Stimulation systemConventional AC-PC based implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the thalamic/subthalamic region (Vim-cZI). | Device | Conventional AC-PC based implantation of ACTIVA INS DBS system |
| MR-tractography guided implantation of ACTIVA INS DBS systemAlso: Medtronic ACTIVA INS Deep Brain Stimulation systemMR-tractography guided implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the DRT. | Device | MR-tractography guided implantation of ACTIVA INS DBS system |
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
9 secondary outcomes
Effective tremor reduction at 12 months after intervention
Time frame: Baseline, 12 months after neurosurgery
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 measured by calculation of total power at baseline and 6 and 12 months after intervention
Time frame: Baseline, 6 and 12 months after neurosurgery
Quality of Life: QUEST, SF-36
Time frame: Baseline, 6 and 12 months after neurosurgery
Size of VAT
Time frame: Day 0 (Day of neurosurgery)
Effective contact position with respect to DRT and AC-PC coordinates
Time frame: Day 0 (Day of neurosurgery)
Duration of neurosurgery
Time frame: Day 0 (Day of neurosurgery)
Changes in BDI
Time frame: Baseline, 6 and 12 months after neurosurgery
Assessment of (Serious) Adverse Events related to intervention
Time frame: Up to 12 months after neurosurgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 22886006Zappia 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.
- Background: PubMed 2940473Koller 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.
- Background: PubMed 24324335Chopra 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.
- Background: PubMed 8592222Benabid 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.
- Background: PubMed 23036448Deistung 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.
- Background: PubMed 20173566Lemaire 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.
- Background: PubMed 21553318Coenen 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.
- Background: PubMed 25161000Coenen 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.
- Background: PubMed 21242831Coenen 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.
- Background: PubMed 25248076Torres 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.
- Background: PubMed 22377809Klein 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.
- Derived from this study: PubMed 28007690Sajonz 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.
Related trials for Essential Tremor
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
Essential Tremor
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Phenotype/Genotype Correlations in Movement Disorders
Movement Disorder
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker A Coenen, MD principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional AC-PC based implantation of ACTIVA INS DBS system and MR-tractography guided implantation of ACTIVA INS DBS system in people with Essential Tremor, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volker A Coenen, MD (+49 761 270 ext. 50630, stereotaxie@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor reduction defined by the difference in FTMTRS at 6 months after intervention to baseline (time frame: Baseline, 6 months after neurosurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491554, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.