Obsessive-Complusive Disorder Clinical Trial
Official title:
Analysis of Visual-Motor Task Electrophysiological Activity During Deep Brain Stimulation for Treatment-Resistant Movement Disorders
| Verified date | July 6, 2017 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Objective
The objective of this pilot study is to characterize the abnormal neuronal firing patterns of
basal ganglia neurons and those in the premotor cortex in patients with treatment-resistant
movement disorders undergoing deep brain stimulation (DBS) surgery.
Study population
Fifteen adult patients with treatment-resistant movement disorders who are undergoing deep
brain stimulation surgery at Suburban Hospital, Bethesda, Maryland, will be studied.
Design
This is a physiology study of treatment-resistant movement disorder patients who have been
scheduled for implantation of a deep brain stimulation device into the Nucleus accumbens.
Prior to surgery, patients will learn a rewarded visual-motor task and undergo
magnetoencephalography. The task will be repeated during DBS surgery, with collection of
information on electrical activity including single neuronal unit and local field potentials.
The task and MEG will be repeated 3-4 months after surgery. The collected data will be
analyzed for coherence patterns during rest and rewarded movements.
Outcome measures
We plan to characterize and quantify the oscillatory activity present in motor circuits of
treatment-resistant movement disorder patients during rewarded visually guided movements. We
hypothesize that during visually guided movements, neuronal coherence will be significantly
increased relative to resting periods. Thus, by better understanding the alteration in
oscillatory patterns in these patients, we hope to develop better DBS stimulation paradigms
in order to better treat this disease in the future.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 6, 2017 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
- INCLUSION CRITERIA: Adult patients (over 18 years of age) with severe treatment-resistant ET or PD who are scheduled for deep brain stimulation surgery at Suburban Hospital Able to provide Informed Consent EXCLUSION CRITERIA: Subjects who are not willing or able to safely tolerate the study procedures Subjects who have untreated depression or psychiatric disorder Subjects who use illicit substances Subjects who are pregnant Subjects who are claustrophobic Subjects who have metallic dental fillings. Subjects who have any of the following: cardiac pacemaker; implanted cardiac defibrillator; aneurysm clip; neuro or bone stimulator; insulin or infusion pump; implanted drug infusion device; cochlear, otologic, or ear implant; prostate radiation seeds; IUD (intrauterine device); transdermal medication patch (Nitro); any type of prosthesis (eye, penile); heart valve prosthesis; shunt (spinal/intraventricular); wire sutures or surgical staples; bone/joint pin, screw, nail, plate; body tattoos or makeup (eyeliner/lip); body piercing(s) (non-removable); breast tissue expander; any metallic implants or objects. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | George Washington University |
Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. Review. — View Citation
Alexander GE, Crutcher MD. Preparation for movement: neural representations of intended direction in three motor areas of the monkey. J Neurophysiol. 1990 Jul;64(1):133-50. — View Citation
Alexander GE, DeLong MR, Strick PL. Parallel organization of functionally segregated circuits linking basal ganglia and cortex. Annu Rev Neurosci. 1986;9:357-81. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary objective of this trial is to evaluate and quantify neuronal coherence in basal ganglia structures at rest and during rewarded movement. | |||
| Secondary | The latency and amplitude of evoked activity related to decision-making processing. We will also measure the reaction times and the number of errors. |