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?
- 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 3 years and 7 months.
- 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.