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Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders

ConditionMovement Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of this study is to investigate the brain activity associated with motor and non-motor symptoms of movement disorders, including Parkinson's disease (PD) and essential tremor. These movement disorders commonly have significant non-motor features, such as depression, cognitive and memory impairment, decreased attention, speech and language disturbances, and slower processing speeds. The investigators are interested in the brain activity associated with these motor and non-motor symptoms, and propose to investigate changes in brain activity while the investigators perform recordings of the surface and deep structures of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eligible for DBS surgery based on multi-disciplinary consensus review

Have a diagnosis of Parkinson's disease or Essential Tremor

A minimum of 18 years of age

Willingness to participate in the paradigms described in the protocol

Disqualifiers

Inability to provide full and informed consent

Are not surgical candidates due to co-morbid conditions or pregnancy

Have not undergone an adequate trial of conservative medical management

Have a clinical presentation for which DBS surgery is not indicated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Response Inhibition and Deep Brain Stimulation in Parkinson's disease

    Procedure/Surgery

    After creation of the burr hole and prior to DBS electrode placement, 1-2 subdural strip electrodes will be placed anteriorly or posteriorly from the cranial opening. These electrodes are routinely placed using this technique for seizure mapping, with arrays of electrodes (up to 6) being placed around the perimeter of the opening.14 Subdural strips vary in length and contact size (e.g., the 6-contact Ad-Tech strip), and are currently placed predominantly for studies of sensorimotor function,13 including at our institution (IRB-140327003). Placement over prefrontal areas is performed at other institutions.11-13 The DBS surgery will then proceed according to routine practice, and following lead placement in the optimal desired location, the research task paradigm will begin.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Accuracy via Simon Task (% correct)

In the Simon task, participants are instructed to respond with a right or left button press (Right = Red, Left = Blue) according to how a word is printed on a screen ("RED" or "BLUE"), regardless of the color in which the word is printed. This is a measurement of accuracy (% correct, ranging from 0-100, with higher scores indicating better performance)

Time frame
Baseline
2

Response times via Simon Task (sec)

In the Simon task, participants are instructed to respond with a right or left button press according to the word "RIGHT" or "LEFT" that appears on a screen, regardless of where on the screen it actually appears. This is a measurement response times (continuous measure, from 0-4000 milliseconds) between correct and incorrect responses.

Time frame
Baseline
3

Simon Effect on Response times (sec)

Participants will perform the Simon task as described, and the Simon effect will be calculated as the difference in response times between congruent and incongruent trials

Time frame
Baseline
4

Simon Effect on Accuracy (% correct)

Participants will perform the Simon task as described, and the Simon effect will be calculated as the difference in accuracy between congruent and incongruent trials

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov
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