Targeted brain stimulation reduces depression
- Trial ID
- NCT06467695
- Official Title
- The Effect of MRI-Guided Transcranial Direct Current Stimulation on Cognitive and Affective Symptoms in Persons With Parkinson's Disease and Controls
- Goal
- Targeted brain stimulation reduces depression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of South Alabama
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease, Depressive Symptoms
- Interventions
- BIOPAC Stimsola, BIOPAC Stimsola Sham (zero amps)
Summary For Families
The goal is to find out whether MRI-guided transcranial direct current stimulation can reduce cognitive problems and depressive symptoms in people with Parkinson's, with healthy controls included for comparison. Using the BIOPAC Stimsola, a noninvasive device delivers a very weak, targeted electrical current through the scalp guided by each person’s MRI to gently boost or quiet activity in brain regions involved in mood and thinking, while EEG records brain responses; a sham setting uses zero amps so researchers can separate real effects from placebo. The trial is recruiting adults 19 to 65, with the Parkinson's group needing a physician diagnosis and elevated depression on the Beck Depression Inventory, score 20 or higher, and all participants must be able to travel for EEG and tDCS sessions. People with epilepsy, significant traumatic brain injury, or atypical Parkinson's are excluded, and those with deep brain stimulation may join only if their physician agrees to monitor them.
Locations
- University of South Alabama, Mobile, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying BIOPAC Stimsola. The goal is to find out whether MRI-guided transcranial direct current stimulation can reduce cognitive problems and depressive symptoms in people with Parkinson's, with healthy controls included for comparison. Using the BIOPAC Stimsola, a noninvasive device delivers a very weak, targeted electrical current through the scalp guided by each person’s MRI to gently boost or quiet activity in brain regions involved in mood and thinking, while EEG records brain responses; a sham setting uses zero amps so researchers can separate real effects from placebo. The trial is recruiting adults 19 to 65, with the Parkinson's group needing a physician diagnosis and elevated depression on the Beck Depression Inventory, score 20 or higher, and all participants must be able to travel for EEG and tDCS sessions. People with epilepsy, significant traumatic brain injury, or atypical Parkinson's are excluded, and those with deep brain stimulation may join only if their physician agrees to monitor them.
- Who can participate?
- Participants must be between 19 Years and 65 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.