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Imaging-based evaluation of the treatment of tremor by targeted lesioning of the brain


- candidate number23667
- NTR NumberNTR5704
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2016
- Secondary IDs2015/597 METc
- Public TitleImaging-based evaluation of the treatment of tremor by targeted lesioning of the brain
- Scientific TitleEvaluation of the cerebello-rubro-thalamic tract after (sub)thalamotomy
- ACRONYM
- hypothesisThis study aims to improve the optimal surgical target planning for thalamotomy, and to optimize the selection process of individual patients for either DBS or (sub)thalamotomy.
- Healt Condition(s) or Problem(s) studiedImaging, Tremor
- Inclusion criteria- Adult patients (>18 years old)
- Treatment for tremor with (sub)thalamotomy in the UMCG
- Written informed consent
- Exclusion criteria- Contra-indications to MRI examination (e.g. heart pacemaker, metal foreign body in eye, aneurysm clip in brain, severe claustrophobia)
- Implantation of DBS electrodes
- Patients with a life expectancy less than 6 months
- Patients physically not able to lie flat for one hour
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2016
- planned closingdate1-feb-2017
- Target number of participants19
- Interventions- Tremor registration and video registration, followed by a clinical tremor rating scale assessment
- Short questionnaire about patient satisfaction
- Repeat MRI with diffusion weighted imaging
- Primary outcomeIn all patients: relation between tremor severity and localization of the lesion. Relation between clinical tremor severity and radiographic (DTI) features of the cerebello-rubro-thalamic tract.

- The difference in localization of the lesioned area in the brain towards the preoperative assessed target measured in millimetres
- The volume of the cerebello-rubro-thalamic tract involved in the lesioned area and compared to the contralateral side
- Tremor severity as measured by accelerometers (amplitude and frequency) and the Bain & Findley Clinical Tremor Rating Scale
- Secondary outcomePatient satisfaction after (sub)thalamotomy using a short questionnaire (VAS score).
- TimepointsMRI and tremor registration will be scheduled on the same day if possible.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. D.L.M. Oterdoom
- CONTACT for SCIENTIFIC QUERIESDr. J.M.C. van Dijk
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryRationale: In the neurosurgical treatment for medication-refractory debilitating tremor, deep brain stimulation (DBS) is nowadays far more popular than thalamotomy. But in selected cases lesioning may be preferable over DBS. This study aims to learn more about the therapeutic mechanism of (sub)thalamotomy. A novel MRI technique, Diffusion Tensor Imaging (DTI), can be used to detect microstructural changes in the white matter. It is also applied to visualize white matter tracts in the brain.

Objective: This evaluation aims to improve the optimal surgical target planning for thalamotomy, and to optimize the selection process of individual patient for either DBS or thalamotomy.

Study design: Participants will have a clinical evaluation consisting of:
- Tremor registration and video registration, followed by a clinical tremor rating scale assessment
- Short questionnaire about patient satisfaction
- Repeat MRI with diffusion weighted imaging

Study population: A cohort of 19 patients who were treated with (sub)thalamotomy in the UMC Groningen is eligible.

Main study endpoints: - Difference in localization of lesioned area towards preoperative assessed target (in millimeters)
- Volume of the cerebello-rubro-thalamic tract involved in the lesioned area and compared to the contralateral side
- Tremor severity as measured by accelerometers (amplitude and frequency) and the Bain & Findley Clinical Tremor Rating Scale
- Patient satisfaction after (sub)thalamotomy using a short questionnaire (VAS score)
- Main changes (audit trail)
- RECORD28-jan-2016 - 25-apr-2016


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