CClinicalTrials.gg
Status unknownNCT01962194Updated Oct 14, 2013

Mapping and Stimulating the Limbic Areas of the Subthalamic Nucleus

An interventional study of Deep Brain Stimulation in Mapping the Limbic STN Using Neuronal Responses, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-10-14.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Mapping the Limbic STN Using Neuronal Responses
03

In context

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 660 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria of PD patients:

  1. Patients with PD who meet accepted criteria for DBS surgery:

    i. 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.

  2. Age 40-75 years
  3. Male or female
  4. Competent and willing to give written informed consent

Exclusion Criteria of PD patients:

  1. A diagnosis of severe major depression disorder (MDD) with psychotic features
  2. Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2]
  3. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
  4. Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) \< 75 and the Frontal Assessment Battery (FAB) \< 10.
  5. Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
  6. Any clinically significant abnormality on preoperative MRI
  7. Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
  8. Pregnant and/or woman of childbearing age not using effective forms of birth control

Inclusion criteria of OCD patients:

  1. Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID-IV)
  2. Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 25
  3. 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.
  4. Either drug free or on a stable drug regimen for at least 6 weeks before study entry
  5. General good overall health
  6. Age 20-70 years
  7. Male or female
  8. Competent and willing to give written informed consent.

Exclusion Criteria of OCD patients:

  1. A diagnosis of severe major depression disorder (MDD) with psychotic features
  2. Significant suicidal risk [Hamilton Depression scale item 3 (suicide) >2].
  3. Comorbidity with any primary Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
  4. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
  5. Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) \< 75 and the Frontal Assessment Battery (FAB) \< 10.
  6. Significant cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably
  7. Any another current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder
  8. Any clinically significant abnormality on preoperative MRI
  9. Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
  10. Pregnant and/or woman of childbearing age not using effective forms of birth control
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    PD and OCD paients for DBS intervention

    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.

    Device: Deep Brain Stimulation

Interventions

  • DeviceDeep Brain Stimulation

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: two years

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01962194
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Oct 14, 2013
Start date
Dec 2013
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Oct 14, 2013

Study contacts

Renana Eitan, MD
Contact
renanaeitan@gmail.com
Renana Eitan, MD
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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