Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease

NCT04151043 — Not applicable, Completed, 24 participants, University of Aarhus

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Registry	NCT04151043
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, basic science
Enrollment	24 (Actual)
Sponsor	University of Aarhus (Other); collaborators: Aarhus University Hospital
Conditions	Pain
Interventions	Suggestions, Deep brain stimulation (Behavioral, device)
Dates	start 2019-12-01, primary completion 2022-07-01, completion 2022-07-01, first posted 2019-11-05, last updated 2023-05-10
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Verbal suggestion	Other	Behavioral: Suggestions; Device: Deep brain stimulation
No suggestion	Other	Behavioral: Suggestions; Device: Deep brain stimulation

Suggestions (Behavioral): Verbal suggestions or no suggestions about treatment outcome
Deep brain stimulation (Device): Regulation of deep brain stimulation intensity

+Outcome measures

Primary outcomes

Numerical rating scale (NRS) (Change) [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.]: A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective chronic and evoked pain in all study conditions.
Numerical rating scale (NRS) (Change) [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.]: A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective expectations to chronic and evoked pain in all study conditions.

Secondary outcomes

Unified Parkinson's Disease Rating Scale (UPDRS) (Change) [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.]: Motor symptoms related to Parkinson's disease are assessed using the Unified Parkinson's Disease Rating Scale, part III in all study conditions.

+Eligibility

Sex: All

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)

+Locations (1)

Facility	City	Country	Status
Department of Psychology and Behavioural Sciences, Aarhus University	Aarhus	Denmark