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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Behavioral: Suggestions; Device: Deep brain stimulation

• Registration Number: NCT04151043
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-05
• Study Start: 2019-12-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Verbal suggestion	Suggestions	-
Verbal suggestion	Deep brain stimulation	-
No suggestion	Suggestions	-
No suggestion	Deep brain stimulation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Psychology and Behavioural Sciences, Aarhus University; 🇩🇰 Aarhus, Denmark