| NCT ID | NCT04957095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-02-18 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-02-18 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological disorders, like Parkinson's disease (PD) and essential tremor (ET), cause abnormalities in these brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases and is thought to help patients by modulating brain networks responsible for movement. Levodopa medication is also used to modulate this brain networks in patients with PD. The overall objective is to develop a unified theory of basal ganglia thalamocortical (BGTC) circuit dynamics that accounts for disease symptomatology, movement, and their inter-relationship. The underlying hypothesis, is that the rigidity and bradykinesia of PD are fundamentally related to excessive functional coupling across nodes in the BGTC motor circuit impeding effective information flow. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation, cortical stimulation, and pharmacologic therapy in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease who have been recommended to undergo deep brain stimulation for management of their movement disorder * Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities * Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes Exclusion Criteria: * Patients with recent use (within one week) of anticoagulant or antiplatelet agents * Neurocognitive testing indicating amnestic cognitive deficits
Contact & Investigator
Nader Pouratian, MD, PhD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT04957095 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04957095 currently recruiting?
Yes, NCT04957095 is actively recruiting participants. Contact the research team at nader.pouratian@utsouthwestern.edu for enrollment information.
Where is the NCT04957095 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04957095 clinical trial?
NCT04957095 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Nader Pouratian, MD, PhD at University of Texas Southwestern Medical Center. The trial plans to enroll 120 participants.
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