Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02692183
Status:
UNKNOWN
Last Update Posted:
2016-02-25
First Post:
2016-02-22
Brief Title:
Mapping Functional Networks of Brain Activity Using EEG in Patients With Essential Tremor or Parkinson Disease Before and After MR-guided Focused Ultrasound Thalamotomy for Tremor
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Mapping Functional Networks of Brain Activity Brain Network Activation BNA Based on Analysis of Evoked Response Potential ERP Signals in Patients With Essential Tremor or Parkinson Disease Before and After MR-guided Focused Ultrasound FUS Thalamotomy for Tremor
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
A cornerstone in PD and ET research is the investigation of neurophysiological changes as potential bio-markers that could help in tracking disease progression and response to therapy Electroencephalography EEG could provide a non-invasive and relatively inexpensive tool for identification of such bio-markers In this study the investigators will use high-density electroencephalographic EEG recordings in order to develop a platform of sensitive and reliable bio-markers for disease progression and response to MR-guided Focused ultrasound thalamotomy FUS-T intervention for tremor
Detailed Description:
Parkinsons disease PD is a common neurodegenerative disease the neurochemical hallmark of which is dopamine deficiency in nigrostriatal pathways and characterized clinically by a movement disorder consisting of rest tremor bradykinesia rigidity impairment of postural reflexes and gait difficulties The disease may leads to severe neurological dysfunction within several years
Essential tremor ET is a neurological disorder characterized by the presence of action tremor in different body parts mainly in the hands head larynx voice box tongue and chin The lower body is rarely affected
INSIGHTEC uses MR guided Focused Ultrasound to perform a non-invasive thalamotomy to relieve medication refractory tremor in patients with ET or tremor-dominant PD The effect of MRgFUS is based on tissue destruction targeted to the Vim nucleus of the thalamus which enables a highly accurate and controlled thermal effect
Ultrasound energy is delivered across the skull without an incision or craniotomy heating the targeted tissue above the protein denaturation threshold at temperatures near 60C Prior to the delivery of high temperatures destructive sonication delivery of lower energy focused ultrasound allows for proper anatomic localization as well as physiologic evaluation of symptom relief andor any unwanted side effects This process allows for adjustments before making a permanent lesion Treatment effects are immediate and the several hour treatment is generally well tolerated with mild sedatives
The FUS-T procedure was shown as an efficacious procedure for tremor in both ET patients and PD patients Elminda developed an algorithm of Brain network activation BNA Mapping Functional Networks of Brain Activity Using EEG
Studying brain morphology and function with Neuroimaging and electrophysiological measures is critical for our understanding of the pathology and pathophysiology of PD and ET
The BNA network can shed a lite on the brain connectivity changes that occur as a result treatment in neurological patients in this case patients with either PD or ET tremor going through FUS-T
BNA can help understanding the effects of FUS-T on the brain physiology and perhaps to identify biomarkers that may serve as tools for chosing the best candidates for this treatemnt and optimal treatment parameters
Essential tremor ET is a neurological disorder characterized by the presence of action tremor in different body parts mainly in the hands head larynx voice box tongue and chin The lower body is rarely affected
INSIGHTEC uses MR guided Focused Ultrasound to perform a non-invasive thalamotomy to relieve medication refractory tremor in patients with ET or tremor-dominant PD The effect of MRgFUS is based on tissue destruction targeted to the Vim nucleus of the thalamus which enables a highly accurate and controlled thermal effect
Ultrasound energy is delivered across the skull without an incision or craniotomy heating the targeted tissue above the protein denaturation threshold at temperatures near 60C Prior to the delivery of high temperatures destructive sonication delivery of lower energy focused ultrasound allows for proper anatomic localization as well as physiologic evaluation of symptom relief andor any unwanted side effects This process allows for adjustments before making a permanent lesion Treatment effects are immediate and the several hour treatment is generally well tolerated with mild sedatives
The FUS-T procedure was shown as an efficacious procedure for tremor in both ET patients and PD patients Elminda developed an algorithm of Brain network activation BNA Mapping Functional Networks of Brain Activity Using EEG
Studying brain morphology and function with Neuroimaging and electrophysiological measures is critical for our understanding of the pathology and pathophysiology of PD and ET
The BNA network can shed a lite on the brain connectivity changes that occur as a result treatment in neurological patients in this case patients with either PD or ET tremor going through FUS-T
BNA can help understanding the effects of FUS-T on the brain physiology and perhaps to identify biomarkers that may serve as tools for chosing the best candidates for this treatemnt and optimal treatment parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None