Investigating how deep brain stimulation affects brain networks in Parkinson's disease
Cortical Network Modulation by Subthalamic Nucleus Deep Brain Stimulation
This study is testing how deep brain stimulation affects brain activity in people with Parkinson's disease to see if it can improve movement and understand any thinking problems that might come with it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT04922411 on ClinicalTrials.gov |
What this trial studies
This study explores the effects of deep brain stimulation (DBS) of the subthalamic nucleus on cortical networks in patients with Parkinson's disease. Using high-density diffuse optical tomography (HD-DOT), researchers aim to understand the neural mechanisms behind the motor benefits and cognitive side effects associated with DBS. Participants will undergo motor and cognitive assessments, questionnaires, HD-DOT scanning, and MRI scans to gather comprehensive data on brain activity and connectivity. The findings could lead to improved clinical optimization of DBS and identify new targets for less invasive neuromodulation techniques.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 50 to 75 with clinically definite Parkinson's disease who are consented for bilateral STN DBS surgery.
Not a fit: Patients who do not have clinically definite Parkinson's disease or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of DBS in treating Parkinson's disease while minimizing adverse cognitive and mood-related side effects.
How similar studies have performed: While there have been studies on DBS and its effects, the use of HD-DOT for real-time assessment of cortical networks in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pilot Group: Participants who enroll as part of the Pilot Group of up to10, will follow the same inclusion criteria as the Control group with the exception of matching the age and sex distribution of the DBS group. Pilot participants will be males or females between 20 and 75 years of age who do not meet criteria for clinically definite PD. * Control Group: Participants who enroll as part of the Control Group will match the age and sex distributions of the DBS groups. Control participants will be males or females between 50 and 75 years of age who do not meet criteria for clinically definite PD. * Pre-Surgical DBS Group: Participants with PD who have been clinically consented for bilateral STN DBS surgery will be recruited from the DBS program within the Movement Disorders Clinic at WUSM. Pre-surgical STN DBS patients will be males or females between 50 and 75 years of age who meet criteria for clinically definite PD. * Post-Surgical DBS Group: Participants with PD who have had bilateral STN DBS surgery will be males or females between 50 and 75 years of age who meet criteria for clinically definite PD. Exclusion Criteria: * Pilot Group: Exclusions include any significant past or current neurologic or psychiatric diagnosis or any other condition which could interfere with testing (e.g. severe visual loss, non-English speaking, and illiteracy) and contraindications for MRI. * Control Group: Exclusions include any significant past or current neurologic or psychiatric diagnosis or any other condition which could interfere with testing (e.g. severe visual loss, non-English speaking, and illiteracy) and contraindications for MRI. * Pre-Surgical DBS Group: Patients will have already passed clinical screening for neurological and psychiatric comorbidities, including dementia. From this group of potential subjects, we will also exclude those with contraindications for MRI pre-surgically, inability to tolerate off medication or off DBS states, or any other condition which could interfere with testing (e.g. severe visual loss, non-English speaking, illiteracy). * Post-Surgical DBS Group: Patients will have already passed clinical screening for neurological and psychiatric comorbidities, including dementia. From this group of potential subjects, we will also exclude those with contraindications for MRI pre-surgically, clinically determined dementia manifesting after surgery, significant complications of surgery (e.g. stroke), inability to tolerate off medication or off DBS states, or any other condition which could interfere with testing (e.g. severe visual loss, non-English speaking, illiteracy).
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Tamara G Hershey — Washington University Medical School
- Study coordinator: Samantha Ranck, MSW, MA, LPC
- Email: blankens@wustl.edu
- Phone: 314-362-6514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.