Change of stimulation amplitudes i… for Parkinson's (NCT05182892)
Reduce stimulation induced speech problems
- Trial ID
- NCT05182892
- Official Title
- REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
- Goal
- Reduce stimulation induced speech problems
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Study Type
- INTERVENTIONAL
- Enrollment
- 45 participants
- Conditions
- Parkinson Disease
- Interventions
- Change of stimulation amplitudes in dopaminergic OFF drug state
Summary For Families
The goal is to help with the speech problems of Parkinson's that get better with levodopa while at the same time reducing the speech worsening some people get from deep brain stimulation of the subthalamic nucleus, using computerized sound analysis. The team records and analyzes speech while turning stimulation on and off, raising stimulation strength, and when possible testing people after an overnight withdrawal of their Parkinson's medicine, and they will make stimulation maps to find brain regions and settings that help speech while avoiding regions that make it worse. They will also compare the computer measurements to ratings by three blinded speech therapists and try routine programming changes that clinicians use to reduce stimulation-related speech problems, then reassess speech over a few weeks. The study is for adults 18 and older with idiopathic Parkinson's who have had bilateral subthalamic nucleus deep brain stimulation for at least three months and who developed speech worsening linked to their stimulation or whose speech improves when stimulation is reduced; participants must speak Swiss-German or German, be able to consent, and people with other causes of speech problems, major cognitive impairment, recent medication or stimulation changes, or pregnancy are excluded.
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 Change of stimulation amplitudes in dopaminergic OFF drug state. The goal is to help with the speech problems of Parkinson's that get better with levodopa while at the same time reducing the speech worsening some people get from deep brain stimulation of the subthalamic nucleus, using computerized sound analysis. The team records and analyzes speech while turning stimulation on and off, raising stimulation strength, and when possible testing people after an overnight withdrawal of their Parkinson's medicine, and they will make stimulation maps to find brain regions and settings that help speech while avoiding regions that make it worse. They will also compare the computer measurements to ratings by three blinded speech therapists and try routine programming changes that clinicians use to reduce stimulation-related speech problems, then reassess speech over a few weeks. The study is for adults 18 and older with idiopathic Parkinson's who have had bilateral subthalamic nucleus deep brain stimulation for at least three months and who developed speech worsening linked to their stimulation or whose speech improves when stimulation is reduced; participants must speak Swiss-German or German, be able to consent, and people with other causes of speech problems, major cognitive impairment, recent medication or stimulation changes, or pregnancy are excluded.
- Who can participate?
- Participants must be at least 18 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 2 in 3 chance (roughly 67%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- There is a baseline visit and two follow-up visits: V1 between 0-6 weeks after baseline, and V2 between 6-12 weeks after V1.
- 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.