No registrations found.
ID
Source
Health condition
Thalamotomy; lesioning; tremor; DTI
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
- 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 outcome
Patient satisfaction after (sub)thalamotomy using a short questionnaire (VAS score).
Background summary
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)
Study objective
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.
Study design
MRI and tremor registration will be scheduled on the same day if possible.
Intervention
- Tremor registration and video registration, followed by a clinical tremor rating scale assessment
- Short questionnaire about patient satisfaction
- Repeat MRI with diffusion weighted imaging
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4462 |
| NTR-old | NTR5704 |
| Other | METc : 2015/597 |