Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909839
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2023-06-09
Brief Title:
The STEREO-DBS ET Study 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation in Essential Tremor
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
The STEREO-DBS Study 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation in Essential Tremor
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEREO-ET
Brief Summary:
Rationale Deep brain stimulation DBS of the thalamus is an effective surgical treatment for the patients with advanced essential tremor despite optimal pharmacological treatment However individual improvement after DBS remains variable and 20 of patients experience side effects To date DBS-electrode placement and settings in the highly connected thalamus are based on 15-Tesla or 3-Tesla MR-images These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections By using structural 7-Tesla MRI 7T MRI connectivity to visualize malfunctioning brain networks DBS-electrode placement and activation can be individualized
Objective Primary objective of the study is to determine whether visualisation of cortical projections originating in the thalamus and the position of the DBS electrode relative to these projections using 7T MRI improves tremor as measured by the clinically validated Essential Tremor Rating Assessment Scale after six months of DBS
Secondary outcomes are disease related daily functioning adverse effects operation time quality of life patient satisfaction with treatment outcome and patient evaluation of treatment burden
Study design The study will be a single center prospective observational study
Study population Enrollment will be ongoing from June 2023 Intervention if applicable No intervention will be applied Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database
Main study parametersendpoints The primary outcome measure is the change in motor symptoms as measured by the disease-specific Essential Tremor Rating Assessment Scale TETRAS This is measured after 6 months of DBS as part of standard care The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status Quality of Life in Essential Tremor Questionnaire patient satisfaction with the treatment patient evaluation of treatment burden operating time hospitalization time change of tremor medication side effects and complications
Nature and extent of the burden and risks associated with participation benefit and group relatedness The proposed observational research project involves treatment options that are standard care in daily practice The therapies will not be combined with other research products Participation in this study constitutes negligible risk according to NFU criteria for human research
Objective Primary objective of the study is to determine whether visualisation of cortical projections originating in the thalamus and the position of the DBS electrode relative to these projections using 7T MRI improves tremor as measured by the clinically validated Essential Tremor Rating Assessment Scale after six months of DBS
Secondary outcomes are disease related daily functioning adverse effects operation time quality of life patient satisfaction with treatment outcome and patient evaluation of treatment burden
Study design The study will be a single center prospective observational study
Study population Enrollment will be ongoing from June 2023 Intervention if applicable No intervention will be applied Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database
Main study parametersendpoints The primary outcome measure is the change in motor symptoms as measured by the disease-specific Essential Tremor Rating Assessment Scale TETRAS This is measured after 6 months of DBS as part of standard care The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status Quality of Life in Essential Tremor Questionnaire patient satisfaction with the treatment patient evaluation of treatment burden operating time hospitalization time change of tremor medication side effects and complications
Nature and extent of the burden and risks associated with participation benefit and group relatedness The proposed observational research project involves treatment options that are standard care in daily practice The therapies will not be combined with other research products Participation in this study constitutes negligible risk according to NFU criteria for human research
Detailed Description:
INTRODUCTION AND RATIONALE
Deep brain stimulation DBS is an effective treatment in essential tremor ET a slowly progressive neurological disorder The effect of DBS relies on the modulation of malfunctioning brain networks by delivering electrical pulses within the thalamus However individual improvement after DBS remains variable and 20 of patients experience side effects By using structural 7-Tesla magnetic resonance imaging 7T MRI connectivity to visualize malfunctioning networks DBS-electrode placement and activation can be individualized
Current DBS-electrode placement and settings in the highly connected thalamus are based on 15-Tesla or 3-Tesla MR-images These low resolution modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections Integrated structural 7T MRI network maps will enable brain network-based and patient-specific DBS improving motor symptoms and quality of life
Since the 1980s DBS for ET was targeting the thalamus a deep-seated grey matter brain nucleus Current emphasis in the field of DBS is on neural networks rather than separate nuclei in the brain Several studies showed ET to arise from pathological network activity in cerebellar-thalamic-cortical projections dentato-rubro-thalamic-tract In recent years several DBS groups reported about using MRI to visualize thalamic connectivity and the dentato-rubro-thalamic tract in DBS for ET
The thalamus is part of multiple large brain networks DBS is effective in improving tremor and quality of life for ET patients only by modulating its motor network For improving DBS placement and activation it is essential to understand the networks and the modulatory effect of stimulation Thus far visualization of these networks was limited due to low resolution and the lack of structural connectivity visualising -cerebellar-thalamic-cortical projections using diffusion weighted MRI and probabilistic connectivity
The investigators therefore added 7T T2 FGATIR fast gray matter inversion recovery sequence and diffusion-weighted sequences at the Spinoza Centre and showed that probabilistic thalamic network analyses thalamic segmentation successfully identifies the area within the thalamus that has the highest density of connections with the motor network in ET patients In a recent pilot study the investigators showed the implementation of 7T MRI thalamic segmentation is well suited within the existing surgical workflow By generating a 7-Tesla MRI showing the thalamus coloured motor subdivision this technique clearly visualized this new DBS target
The thalamus and its connections will be visualized using 7T T2 FGATIR and diffusion weighted imaging The major projections of the thalamus will be visualised including projections connecting to primary motor and sendory cortex The location of the electrode using computed tomography will be visualised relative to the segmented subdivisions of the thalamus
The 7T MRI network map generated by combining T2 and diffusion weighted MRI shows the thalamus coloured subdivisions and their cortical projections The result will then show in which thalamic subdivisions the DBS-electrode contact is situated and to which cortical area this projects Clinical test scores of the electrode contact will then be correlated to the network maps Stimulation parameters based on 7T MRI network maps are used to optimize and predict outcome in terms of beneficial clinical effects suppression tremor and side effects speech gait As all network maps are visualised on MRI this will readily enable both individual and group analyses co-registrating maps of multiple patients
In the 350 7T MR-scans the investigators have performed to date we rarely encountered non-compatible implants or severe claustrophobia Every patient undergoes screening with a MRI safety questionnaire and MRI metal detector preventing taking ferromagnetic materials into the MRI 7T MRI is a non-invasive technique which causes no pain and importantly the electromagnetic fields produce no known tissue damage of any kind The MR system may make loud tapping knocking or other noises at times during the procedure Earplugs are provided to prevent problems that may be associated with noise generated by the scanner At all times the patient will be visually monitored and will be able to communicate with the 7T MRI technologist using an intercom system The patient may request to stop the acquisition at any time by using the push button hold by the patient continuously
In sum due to implementation of 7T MRI brain network analysis it is now possibly to directly visualize the motor part of the thalamus In current observational study this technique will be evaluated in a prospective fashion introducing patient specific brain network-guided DBS for ET with delivering a unique and hitherto unavailable treatment and dataset 7T MRI visualizes the anatomical connections of the thalamus for each individual DBS electrode contact Instead of a one-brain-fits all model the tailored network analyses enable personalized precision modelling in DBS
Deep brain stimulation DBS is an effective treatment in essential tremor ET a slowly progressive neurological disorder The effect of DBS relies on the modulation of malfunctioning brain networks by delivering electrical pulses within the thalamus However individual improvement after DBS remains variable and 20 of patients experience side effects By using structural 7-Tesla magnetic resonance imaging 7T MRI connectivity to visualize malfunctioning networks DBS-electrode placement and activation can be individualized
Current DBS-electrode placement and settings in the highly connected thalamus are based on 15-Tesla or 3-Tesla MR-images These low resolution modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections Integrated structural 7T MRI network maps will enable brain network-based and patient-specific DBS improving motor symptoms and quality of life
Since the 1980s DBS for ET was targeting the thalamus a deep-seated grey matter brain nucleus Current emphasis in the field of DBS is on neural networks rather than separate nuclei in the brain Several studies showed ET to arise from pathological network activity in cerebellar-thalamic-cortical projections dentato-rubro-thalamic-tract In recent years several DBS groups reported about using MRI to visualize thalamic connectivity and the dentato-rubro-thalamic tract in DBS for ET
The thalamus is part of multiple large brain networks DBS is effective in improving tremor and quality of life for ET patients only by modulating its motor network For improving DBS placement and activation it is essential to understand the networks and the modulatory effect of stimulation Thus far visualization of these networks was limited due to low resolution and the lack of structural connectivity visualising -cerebellar-thalamic-cortical projections using diffusion weighted MRI and probabilistic connectivity
The investigators therefore added 7T T2 FGATIR fast gray matter inversion recovery sequence and diffusion-weighted sequences at the Spinoza Centre and showed that probabilistic thalamic network analyses thalamic segmentation successfully identifies the area within the thalamus that has the highest density of connections with the motor network in ET patients In a recent pilot study the investigators showed the implementation of 7T MRI thalamic segmentation is well suited within the existing surgical workflow By generating a 7-Tesla MRI showing the thalamus coloured motor subdivision this technique clearly visualized this new DBS target
The thalamus and its connections will be visualized using 7T T2 FGATIR and diffusion weighted imaging The major projections of the thalamus will be visualised including projections connecting to primary motor and sendory cortex The location of the electrode using computed tomography will be visualised relative to the segmented subdivisions of the thalamus
The 7T MRI network map generated by combining T2 and diffusion weighted MRI shows the thalamus coloured subdivisions and their cortical projections The result will then show in which thalamic subdivisions the DBS-electrode contact is situated and to which cortical area this projects Clinical test scores of the electrode contact will then be correlated to the network maps Stimulation parameters based on 7T MRI network maps are used to optimize and predict outcome in terms of beneficial clinical effects suppression tremor and side effects speech gait As all network maps are visualised on MRI this will readily enable both individual and group analyses co-registrating maps of multiple patients
In the 350 7T MR-scans the investigators have performed to date we rarely encountered non-compatible implants or severe claustrophobia Every patient undergoes screening with a MRI safety questionnaire and MRI metal detector preventing taking ferromagnetic materials into the MRI 7T MRI is a non-invasive technique which causes no pain and importantly the electromagnetic fields produce no known tissue damage of any kind The MR system may make loud tapping knocking or other noises at times during the procedure Earplugs are provided to prevent problems that may be associated with noise generated by the scanner At all times the patient will be visually monitored and will be able to communicate with the 7T MRI technologist using an intercom system The patient may request to stop the acquisition at any time by using the push button hold by the patient continuously
In sum due to implementation of 7T MRI brain network analysis it is now possibly to directly visualize the motor part of the thalamus In current observational study this technique will be evaluated in a prospective fashion introducing patient specific brain network-guided DBS for ET with delivering a unique and hitherto unavailable treatment and dataset 7T MRI visualizes the anatomical connections of the thalamus for each individual DBS electrode contact Instead of a one-brain-fits all model the tailored network analyses enable personalized precision modelling in DBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None