Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease
NCT ID: NCT04151043
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2019-12-01
2022-07-01
Brief Summary
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The study includes patients with Parkinson's disease that are exposed to pain stimuli through injection of hypertonic saline. During pain induction and chronic pain evaluation deep brain stimulation treatment is regulated. Pain stimuli and regulation of deep brain stimulation are accompanied by verbal suggestions as to the analgesic effect of deep brain stimulation or no suggestions. During the test session patients evaluate their chronic and evoked pain and expectations.
The study procedure is repeated on two separate test days to investigate pain during deep brain stimulation treatment with or without verbal suggestions. All participants will complete all study conditions with no suggestions and verbal suggestions, respectively.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Verbal suggestion
Suggestions
Verbal suggestions or no suggestions about treatment outcome
Deep brain stimulation
Regulation of deep brain stimulation intensity
No suggestion
Suggestions
Verbal suggestions or no suggestions about treatment outcome
Deep brain stimulation
Regulation of deep brain stimulation intensity
Interventions
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Suggestions
Verbal suggestions or no suggestions about treatment outcome
Deep brain stimulation
Regulation of deep brain stimulation intensity
Eligibility Criteria
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Inclusion Criteria
* Bilateral implanted DBS in the STN during the study or for a minimum of 6 months
Exclusion Criteria
* Dementia
* Untreated depression
* Patients unable to pause anti-parkinsonian medication
* Patients unable to cooperate
* Patients treated with painkillers except paracetamol and NSAID (except if pain and treatment is adequately stable as evaluated by a doctor)
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Department of Psychology and Behavioural Sciences, Aarhus University
Aarhus, , Denmark
Countries
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Other Identifiers
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UAarhus_Sophie
Identifier Type: -
Identifier Source: org_study_id
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