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

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Suggestions
Deep brain stimulation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Psychology and Behavioural Sciences, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Verbal suggestion

No suggestion

Arm Description

Outcomes

Primary Outcome Measures

Numerical rating scale (NRS) (Change)
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)
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

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

Full Information

First Posted
October 28, 2019
Last Updated
May 9, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04151043
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal suggestion
Arm Type
Other
Arm Title
No suggestion
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Suggestions
Intervention Description
Verbal suggestions or no suggestions about treatment outcome
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
Regulation of deep brain stimulation intensity
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS) (Change)
Description
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.
Time Frame
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.
Title
Numerical rating scale (NRS) (Change)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) (Change)
Description
Motor symptoms related to Parkinson's disease are assessed using the Unified Parkinson's Disease Rating Scale, part III in all study conditions.
Time Frame
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Department of Psychology and Behavioural Sciences, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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