This 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.
ID
Bron
Aandoening
Thalamotomy; lesioning; tremor; DTI
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
In 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.<br><br>
- The difference in localization of the lesioned area in the brain towards the preoperative assessed target measured in millimetres<br>
- The volume of the cerebello-rubro-thalamic tract involved in the lesioned area and compared to the contralateral side<br>
- Tremor severity as measured by accelerometers (amplitude and frequency) and the Bain & Findley Clinical Tremor Rating Scale
Achtergrond van het onderzoek
Rationale:
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)
Doel van het onderzoek
This 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.
Onderzoeksopzet
MRI and tremor registration will be scheduled on the same day if possible.
Onderzoeksproduct en/of interventie
- Tremor registration and video registration, followed by a clinical tremor rating scale assessment
- Short questionnaire about patient satisfaction
- Repeat MRI with diffusion weighted imaging
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patients (>18 years old)
- Treatment for tremor with (sub)thalamotomy in the UMCG
- Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4462 |
| NTR-old | NTR5704 |
| Ander register | METc : 2015/597 |