Dopaminergic OFF drug state for Parkinson's (NCT05765110)
Speech tracks movement mood thinking
- Trial ID
- NCT05765110
- Official Title
- SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
- Goal
- Speech tracks movement mood thinking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- Parkinson Disease
- Interventions
- Dopaminergic OFF drug state, DBS OFF state, Dopaminergic ON drug state, DBS ON state
Summary For Families
Researchers want to see whether computerized analysis of speech can reliably and objectively detect the moment-to-moment changes in movement, mood, and thinking that people with Parkinson's disease experience. They will record and analyze speech using computer tools while testing people when they are on and off their Parkinson's medication and with deep brain stimulation turned on and off, and they will include healthy volunteers for comparison. The study enrolls adults over 30 and up to 75 years old with Parkinson's diagnosed by standard clinical criteria who speak German or French, with or without deep brain stimulation implants, and who do not have major thinking problems or other brain diseases; healthy control volunteers are adults aged 50 to 70 who speak German or French.
Locations
- Czech Technical University Prague, Prague, Czechia
- University Hospital Inselspital, Berne, Bern, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dopaminergic OFF drug state. Researchers want to see whether computerized analysis of speech can reliably and objectively detect the moment-to-moment changes in movement, mood, and thinking that people with Parkinson's disease experience. They will record and analyze speech using computer tools while testing people when they are on and off their Parkinson's medication and with deep brain stimulation turned on and off, and they will include healthy volunteers for comparison. The study enrolls adults over 30 and up to 75 years old with Parkinson's diagnosed by standard clinical criteria who speak German or French, with or without deep brain stimulation implants, and who do not have major thinking problems or other brain diseases; healthy control volunteers are adults aged 50 to 70 who speak German or French.
- Who can participate?
- Participants must be between 30 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 4 years.
- 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 a group that receives no study treatment (you would continue your usual care) alongside the treatment groups. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.