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 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.
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.
Inclusion criteria of PD patients:
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.
Exclusion Criteria of PD patients:
Inclusion criteria of OCD patients:
Exclusion Criteria of OCD patients:
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
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.
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
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hadassah Medical Organization