Mapping the Limbic STN Using Neuronal ResponsesNCT01962194
Mapping and Stimulating the Limbic Areas of the Subthalamic Nucleus
A study testing Deep Brain Stimulation in people with Mapping the Limbic STN Using Neuronal Responses, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The investigators hypothesize that the emotional and cognitive areas of the Subthalamic Nucleus (STN) have distinct electrophysiological properties and that specific stimulation of these areas can influence the mental and the emotional state. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Mapping the Limbic STN Using Neuronal Responses
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PD who meet accepted criteria for DBS surgery:
- advanced idiopathic PD ii. long-term levodopa use that leads to decreased efficacy and increased incidence of adverse effects iii. normal cognitive function or mild-moderate cognitive decline (Addenbrooke's Cognitive Examination (ACE) > 75 and the Frontal Assessment Battery (FAB) > 10.
- Age 40-75 years
- Male or female
- Competent and willing to give written informed consent
- Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID-IV)
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- Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 25
- Documented highly treatment refractory OCD; the documentation must demonstrate persistence of severe symptoms and impairment for 5 or more years despite both pharmacological and psychological treatments.
- Either drug free or on a stable drug regimen for at least 6 weeks before study entry
- General good overall health
- Age 20-70 years
- Male or female
- Competent and willing to give written informed consent.
Who cannot join
- A diagnosis of severe major depression disorder (MDD) with psychotic features
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2]
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
- Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) < 75 and the Frontal Assessment Battery (FAB) < 10.
- Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
- Any clinically significant abnormality on preoperative MRI
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- Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
- Pregnant and/or woman of childbearing age not using effective forms of birth control
- A diagnosis of severe major depression disorder (MDD) with psychotic features
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2].
- Comorbidity with any primary Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
- Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) < 75 and the Frontal Assessment Battery (FAB) < 10.
- Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
- Any another current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder
- Any clinically significant abnormality on preoperative MRI
- Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
- Pregnant and/or woman of childbearing age not using effective forms of birth control
Trial locations and contacts
1 site in 1 country.
Renana Eitan, MD contact
Israel1 site
Hadassah Medical Center
Jerusalem, Israel, 91000
Renana Eitan, MD, renanaeitan@gmail.com
About this study
The investigators hypothesize that the emotional and cognitive areas of the Subthalamic Nucleus (STN) have distinct electrophysiological properties and that specific stimulation of these areas can influence the mental and the emotional state. Parkinson's disease (PD; n=5) and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) will be recruited over a period of two years. The patients will be enrolled in a prospective, open label, clinical trial and will be followed for one year. No randomization or blinding will be used in this study.
- Being tested
- Deep Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
In this study we will use implantable Deep Brain Stimulation (DBS) system with local field potential sensing capability. The Device is the Medtronic, Inc DBS Implantable System, "Activa PC+S", which has therapy equivalent to "Activa PC", and has a new sensing programmer.
| Study group | Role | What they receive |
|---|---|---|
| PD and OCD paients for DBS intervention | Experimental | Parkinson's disease (PD; n=5) and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with STN DBS will be recruited over a period of two years. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mapping the limbic-associative STN in human using neuronal (single units & Local Field Potential (LFP)) responses to emotional stimuli during surgery and long term LFP recordings in PD and OCD patients
Mapping the limbic-associative STN in human using neuronal (single units \& Local Field Potential (LFP)) responses to emotional stimuli during surgery and long term LFP recordings in Parkinson's diseae (PD) and Obsessive Compulsive Disorder (OCD) patients
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mapping the Limbic STN Using Neuronal ResponsesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renana Eitan, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962194
- Sponsor's protocol ID
- RE403-HMO-CTIL
- Status last verified
- Jun 2013
- First submitted
- 25 Sep 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping and Stimulating the Limbic Areas of the Subthalamic Nucleus
- ClinicalTrials.gov ID
- NCT01962194
- Acronym / sponsor ID
- RE403-HMO-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Oct 2013 (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.
The investigators hypothesize that the emotional and cognitive areas of the Subthalamic Nucleus (STN) have distinct electrophysiological properties and that specific stimulation of these areas can influence the mental and the emotional state. Parkinson's disease (PD; n=5) and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) will be recruited over a period of two years. The patients will be enrolled in a prospective, open label, clinical trial and will be followed for one year. No randomization or blinding will be used in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD and OCD paients for DBS intervention | Experimental | Device: Deep Brain StimulationParkinson's disease (PD; n=5) and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with STN DBS will be recruited over a period of two years. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with PD who meet accepted criteria for DBS surgery:
- Age 40-75 years
- Male or female
- Competent and willing to give written informed consent
- Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID-IV)
Key exclusion criteria (18 listed)
- A diagnosis of severe major depression disorder (MDD) with psychotic features
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2]
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
- Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) < 75 and the Frontal Assessment Battery (FAB) < 10.
- Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationIn this study we will use implantable Deep Brain Stimulation (DBS) system with local field potential sensing capability. The Device is the Medtronic, Inc DBS Implantable System, "Activa PC+S", which has therapy equivalent to "Activa PC", and has a new sensing programmer. | Device | PD and OCD paients for DBS intervention |
Primary outcome
Mapping the limbic-associative STN in human using neuronal (single units & Local Field Potential (LFP)) responses to emotional stimuli during surgery and long term LFP recordings in PD and OCD patients
Time frame: two years
Mapping the limbic-associative STN in human using neuronal (single units \& Local Field Potential (LFP)) responses to emotional stimuli during surgery and long term LFP recordings in Parkinson's diseae (PD) and Obsessive Compulsive Disorder (OCD) patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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.
Renana Eitan, MD contact
Renana Eitan, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Mapping the Limbic STN Using Neuronal Responses, run by Hadassah Medical Organization at 1 site in Israel.
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 13 inclusion and 18 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 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Renana Eitan, MD (renanaeitan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mapping the limbic-associative STN in human using neuronal (single units & Local Field Potential (LFP)) responses to emotional stimuli during surgery and long term LFP recordings in PD and OCD patients (time frame: two 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 14 Oct 2013.