Clinical trial NCT04151043: Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease
Official title: Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2019-11-05
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates analgesic effects of expectations and deep brain stimulation on chronic and evoked pain in patients with Parkinson's disease.

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.


Eligibility criteria: Inclusion criteria:

* Diagnosis of PD (confirmed by a neurologist)
* Bilateral implanted DBS in the STN during the study or for a minimum of 6 months

Exclusion criteria

* Other neurological or medical disorders (e.g. stroke, neuropathy, diabetes) or other disorders (e.g. musculoskeletal diseases) with expected influence on pain
* 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)

Primary outcomes:
measure: Numerical rating scale (NRS) (Change)
timeFrame: Participants will be tested on two days. The numerical rating scale will be applied to assess chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
measure: Numerical rating scale (NRS) (Change)
timeFrame: Participants will be tested on two days. The numerical rating scale will be applied to assess expectations to chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) (Change)
timeFrame: Participants will be tested on two days. The Unified Parkinson's Disease Rating Scale will be used to evaluate motor symptoms at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Psychology and Behavioural Sciences, Aarhus University
Study officials:
References: