BIOPAC Stimsola for Parkinson's (NCT06467695)
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.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will participate in 15, 46 minute sessions over the course of 4-5 weeks (each session has 2 13 minute stimulation sessions with 20 minutes of rest between).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Questionnaires & surveys (non-invasive); Brain wave recording (EEG) (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.