Detect cognitive decline from speech
- Trial ID
- NCT05765110
- Official Title
- SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
- Goal
- Detect cognitive decline from speech
- 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
The team is looking to see whether patterns in speech can serve as an easy, objective biomarker for emotional state, movement symptoms, and cognitive changes in Parkinson's, so doctors could track these aspects more quickly and accurately. Participants have their voice recorded in different clinical states, comparing dopaminergic OFF versus ON (before and after levodopa or similar meds that improve motor symptoms) and DBS OFF versus ON for those with bilateral subthalamic nucleus stimulation, to find which speech features change with medication and DBS effects. The study seeks people with idiopathic PD over 30 and up to 75 years old, fluent in German or French, with or without bilateral STN DBS, normal cognition (MoCA 24 or higher) and no other brain or speech disorders, and also healthy controls aged 50 to 70 with similar language and cognitive requirements.
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. The team is looking to see whether patterns in speech can serve as an easy, objective biomarker for emotional state, movement symptoms, and cognitive changes in Parkinson's, so doctors could track these aspects more quickly and accurately. Participants have their voice recorded in different clinical states, comparing dopaminergic OFF versus ON (before and after levodopa or similar meds that improve motor symptoms) and DBS OFF versus ON for those with bilateral subthalamic nucleus stimulation, to find which speech features change with medication and DBS effects. The study seeks people with idiopathic PD over 30 and up to 75 years old, fluent in German or French, with or without bilateral STN DBS, normal cognition (MoCA 24 or higher) and no other brain or speech disorders, and also healthy controls aged 50 to 70 with similar language and cognitive requirements.
- 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?
- 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 4 years.
- 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.