Parkinson Disease-tremorNCT02692183
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
An observational study of Parkinson Disease-tremor and Essential Tremor, run by Sheba Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease-tremor, Essential Tremor
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 50 patients with idiopathic PD with tremor 50 patients with Essential tremor.
Who may be able to join
- Patients with essential Tremor and unilateral tremor-dominant Idiopathic Parkinson's Disease -undergoing ExAblate 4000 Transcranial MR guided focused ultrasound (TcMRgFUS) thalamotomy).
Who cannot join
- In the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements.
- Patients with significant psychiatric symptoms or history
- Treatment with neuroleptics.
- Currently with lice or open wounds on scalp.
- Significant sensory deficits, e.g., deafness or blindness
- Current drug abuse or alcoholism.
- Pregnancy or not using a reliable method of birth control
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed description
Parkinson's 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 60°C. 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 and/or 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.
- Conditions
- Parkinson Disease-tremor, Essential Tremor
- Keywords
- Parkinson's disease, ET, EEG, FUS, BNA, Essential tremor
- Medical subject headings
- Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease (PD) tremor patients | Patients with PD before and after MRI guided Focused ultrasound thalamotomy | |
| Essential tremor (ET) patients | Patients with ET before and after MRIFocused ultrasound guided thalamotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG/ ERP recordings
EEG/ERP: Quantitative EEG based on 64 channel acquisition will be performed during the stimulation treatment to search for discriminatory markers of response to stimulation. Sessions will initially comprise a series of both task (evoked potentials/event-related potentials (ERPs, to be determined) and rest states. The task state will principally be evaluated for brain network analysis (BNA, ElMindA, Israel).
Measured: 2 years
Secondary outcomes (1)
computerized gait analysis
Another optional monitoring procedure is a computerized gait analysis of the Mon4t system (iPhone4, Apple®, Cupertino, California, USA): In order to capture the subject position and motion the investigators will use a standard smartphone. Gait will be assessed by the use of a set of wearable accelerometers, gyroscopes and magnetometers which are all included into the smartphone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease-tremorStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- ElMindA Ltd, InSightec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692183
- Sponsor's protocol ID
- SHEBA-SH-2805-15-CTIL
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02692183
- Acronym / sponsor ID
- SHEBA-SH-2805-15-CTIL
- Conditions
- Parkinson Disease-tremor, Essential Tremor
- Keywords
- Parkinson's disease, ET, EEG, FUS, BNA, Essential tremor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- ElMindA Ltd, InSightec
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Parkinson's 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 60°C. 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 and/or 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease (PD) tremor patients | – | –Patients with PD before and after MRI guided Focused ultrasound thalamotomy |
| Essential tremor (ET) patients | – | –Patients with ET before and after MRIFocused ultrasound guided thalamotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 patients with idiopathic PD with tremor 50 patients with Essential tremor.
Key inclusion criteria (1 listed)
- Patients with essential Tremor and unilateral tremor-dominant Idiopathic Parkinson's Disease -undergoing ExAblate 4000 Transcranial MR guided focused ultrasound (TcMRgFUS) thalamotomy).
Key exclusion criteria (7 listed)
- In the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements.
- Patients with significant psychiatric symptoms or history
- Treatment with neuroleptics.
- Currently with lice or open wounds on scalp.
- Significant sensory deficits, e.g., deafness or blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG/ ERP recordings
Time frame: 2 years
EEG/ERP: Quantitative EEG based on 64 channel acquisition will be performed during the stimulation treatment to search for discriminatory markers of response to stimulation. Sessions will initially comprise a series of both task (evoked potentials/event-related potentials (ERPs, to be determined) and rest states. The task state will principally be evaluated for brain network analysis (BNA, ElMindA, Israel).
1 secondary outcome
computerized gait analysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease-tremor and Essential Tremor, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Hassin, MD (03-5305791, sharon.hassin@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG/ ERP recordings (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.