inducement of experimental pain for Parkinson's (NCT05981261)
Assess experimental pain in Parkinsons
- Trial ID
- NCT05981261
- Official Title
- Comparing Pain Intensity and Discomfort in Patients With Parkinson´s Disease and Healthy Controls During Inducement of Mechanical, Thermal, and Chemical Experimental Pain
- Goal
- Assess experimental pain in Parkinsons
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Aarhus
- Study Type
- INTERVENTIONAL
- Enrollment
- 63 participants
- Conditions
- Pain, Parkinson Disease
- Interventions
- inducement of experimental pain
Summary For Families
The team is trying to find out whether people with Parkinson's feel pain differently than healthy people, and whether common treatments like levodopa or deep brain stimulation change how intense or unpleasant triggered pain feels. To do that, they will apply short, controlled mechanical, heat, and chemical stimuli to provoke experimental pain and then measure pain intensity and discomfort, this is an observational comparison rather than a drug test. They are enrolling adults into three groups: healthy volunteers, people with Parkinson's on levodopa, and people with Parkinson's who have DBS. People with other neurological or medical conditions that affect pain, dementia (MoCA score under 24), untreated depression (BDI 15 or higher), inability to cooperate, or regular use of painkillers other than paracetamol (acetaminophen) or NSAIDs unless judged stable by a doctor are excluded.
Locations
- aarhus university Hospital, Aarhus, Denmark
Frequently Asked Questions
- What is this trial testing?
- This trial is studying inducement of experimental pain. The team is trying to find out whether people with Parkinson's feel pain differently than healthy people, and whether common treatments like levodopa or deep brain stimulation change how intense or unpleasant triggered pain feels. To do that, they will apply short, controlled mechanical, heat, and chemical stimuli to provoke experimental pain and then measure pain intensity and discomfort, this is an observational comparison rather than a drug test. They are enrolling adults into three groups: healthy volunteers, people with Parkinson's on levodopa, and people with Parkinson's who have DBS. People with other neurological or medical conditions that affect pain, dementia (MoCA score under 24), untreated depression (BDI 15 or higher), inability to cooperate, or regular use of painkillers other than paracetamol (acetaminophen) or NSAIDs unless judged stable by a doctor are excluded.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 3 years and 7 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Each participant will complete a ≈1 ½ hour test session at the Department of Neurophysiology, Aarhus University Hospital.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.