Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 89 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ways to record brain signals caused by deep brain stimulation (DBS), a treatment that sends electrical pulses to the brain. The goal is to use these signals to guide surgery and treatment settings. It is for adults with advanced Parkinson’s disease who have chosen awake DBS surgery as part of their usual care.
Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Our vision is for a patient's unique electrophysiology to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. Our results will inform directional DBS for PD and serve as a model for translation to other diseases where knowledge on DBS circuit interactions is at an even earlier stage.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be older than 18 and have had Parkinson’s disease for at least 4 years, with at least two signs: shaking, stiffness, or slow movement.
- Have serious movement problems despite medicine, with trouble doing daily tasks, working, or taking part in social activities.
- Have chosen awake DBS surgery, with the study’s brain targets approved by the DBS team. If using both targets, the surgeon must judge this safe.
- Be healthy enough for surgery and study visits. A brain MRI scan must be normal or nearly normal, apart from mild changes expected with advanced Parkinson’s.
- Have taken steady doses of Parkinson’s medicines for at least 28 days. Movement signs must improve by at least 30% with medicine, unless levodopa causes unacceptable side effects.
- Meet the study’s thinking, memory, and depression test limits, with no signs of suicidal thoughts.
- Be able to cooperate during awake surgery, follow-up visits, and changes to medicines and DBS settings. Understand the study and sign a consent form.
- Have health insurance or Medicare that covers routine DBS surgery.
Who can't join
- Be younger than 18, have Parkinson’s for less than 4 years, or have another suspected cause of movement problems or another major brain or nerve disease.
- Have a health problem that makes surgery or stimulation unsafe, need blood thinners that cannot be stopped around surgery, have had bleeding in the brain or repeated unprovoked seizures, or have a higher infection risk from a weakened immune system.
- Need surgery while fully asleep without awake testing, cannot safely receive both targets through one skull opening, or are expected to need DBS on the other side within 1 year after one-sided surgery.
- Have severe depression above the study’s test limit, dementia, a past suicide attempt, current suicidal thoughts or plans, current loss of touch with reality, alcohol or drug abuse, or ongoing trouble controlling urges despite medicine changes.
- Have no clear response to levodopa, or have a stroke, tumor, or abnormal blood vessels causing the movement disorder.
- Have an implanted device, such as a pacemaker or hearing implant; prior DBS or tissue-destroying surgery in the affected brain area; or a need for diathermy, a treatment that heats body tissues.
- For study parts 2 and 3 only: insurance does not cover surgery with the research device, or there was prior DBS surgery on the opposite side of the brain.
- Be breastfeeding, have a positive pregnancy test, or be able to become pregnant without using adequate birth control. Other health or mental health problems that prevent completing the study may also exclude you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion criteria: 1. Age \>18 years and older. 2. Clinically definite, advanced idiopathic PD based on at least 2 of 3 cardinal PD features (tremor, rigidity, and/or bradykinesia). 3. Disease duration of 4 years or more. 4. Participant has elected to undergo awake DBS surgery as part of routine care, and the subthalamic nucleus (STN) or globus pallidus interna (GPi) are recommended by the multidisciplinary DBS committee as the surgical target. 5. For participants who opt for the dual-target strategy, neurosurgery judges that dual-target STN and GPi implant is an appropriate option with acceptable safety profile. 6. Participant is healthy enough to undergo surgery and the research protocol. 7. Normal, or essentially normal, preoperative brain MRI, except for expected mild abnormalities associated with advanced PD. 8. Willingness and ability to cooperate during awake DBS surgery, as well as during post-operative evaluations, adjustments of medications and stimulator settings. 9. Participant's health insurance and/or Medicare covers DBS surgery as part of routine care. 10. Refractory motor symptoms such as dyskinesias, wearing off, and/or motor fluctuations, causing significant disability or occupational dysfunction, despite reasonable attempts at medical management, as determined by our consensus DBS committee. 11. Stable doses of PD medications for at least 28 days prior to baseline assessments. 12. Improvement of motor signs ≥30% with dopaminergic medication as assessed with the use of the Movement Disorders - Unified Parkinson's Disease Rating Scale, part III (MDS-UPDRS III; scores range from 0 to 108, with higher scores indicating worse functioning). One exception to this 30% threshold is patients who have typical features of PD but cannot take levodopa because of unacceptable side effects.19 13. Disease severity ratings above Hoehn and Yahr stage 2.5, defined as unilateral involvement only with minimal or no functional disability, with scores ranging from 0 to 5 and higher scores indicating more severe disease. 14. Score of more than 6 for activities of daily living in the worst "off" medication condition despite medical treatment, as assessed with the use of the MDS-UPDRS II (scores range from 0 to 52, with higher scores indicating worse functioning), or mild-to-moderate impairment in social and occupational functioning (score of 51 to 80% on the Social and Occupational Functioning Assessment Scale with scores ranging from 1 to 100 and lower scores indicating worse functioning). 15. Dementia Rating Scale-2 (DRS-2) score of ≥130 on medications. 16. Beck Depression Inventory II (BDI-II) score of ≤25 on medications. 17. No indication of suicidal ideation or active suicidal thoughts as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRC). 18. Participant expresses understanding of the consent process, terms of the study protocol, is available for follow-up over the length of the study, and signs informed consent. Exclusion criteria: 1. Age \<18 years. 2. Participant's insurance will not cover the costs of surgery with an investigational device (Aims 2 and 3 only). 3. Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation. 4. Duration of disease of \<4 years 5. Clinical team suspects patient will need staged contralateral DBS for clinical symptoms within 1 year of unilateral DBS surgery. 6. Diagnosis or suspicion of atypical parkinsonism (progressive supranuclear palsy, multiple system atrophy, corticobasal syndrome) or drug-induced parkinsonism, or significant neurological disease other than Parkinson's disease. 7. Diagnosis of psychogenic movement disorder based on consensus criteria. 8. Dual-target implant cannot be performed safely from a single burr hole because of anatomic constraints or cortical vascular anatomy, based upon the pre-operative neurosurgery plan. 9. Patient is undergoing DBS electrode placement under general anesthesia without awake electrophysiological and clinical testing during implant. 10. Score of \>25 on the Beck Depression Inventory II, with scores ranging from 0 to 63 and higher scores indicating worse functioning), or history of suicide attempt. 11. An indication of suicidal ideation or active suicide planning as assessed on the Columbia-Suicide Severity Rating Scale. 12. Any current acute psychosis, alcohol abuse or drug abuse. 13. Clinical dementia (score of ≤130 on the Mattis Dementia Rating Scale with scores ranging from 0 to 144 and higher scores indicating better functioning). 14. Ongoing or pervasive impulse control disorder not resolved by reduction of dopaminergic medications. 15. Use of anticoagulant medications that cannot be discontinued during perioperative period. 16. History of hemorrhagic stroke. 17. Current or future risk of immunocompromise that might increase infection risk. 18. History of recurrent of unprovoked seizures. 19. Lack of clear levodopa responsiveness. 20. The presence of an implanted device (e.g., cochlear implant, pacemaker, neurostimulators), whether turned on or off. 21. Prior DBS surgery or ablation within the affected basal ganglion. 22. Prior DBS surgery on the opposite side of the brain (Aims 2 and 3 only). This may allow us to study some participants twice (i.e., in Aim 1 or 2-3, and again in Aim 1 if they return for DBS on the opposite side of the brain as part of routine care). 23. A condition requiring or likely to require the use of diathermy. 24. Structural lesions such as basal ganglionic stroke, tumor, or vascular malformation as etiology of the movement disorder. 25. Any medical or psychological problem that would interfere with completing the study protocol, as determined by the research team. 26. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Study sites (1)
AL
- University of Alabama at Birmingham · Birmingham, AL 35233Christopher Gonzalez · Study contact · 205-975-3732 · clgonzalez@uabmc.eduHarrison Walker, MD · Principal investigatorMore trials in Birmingham