NCT04151043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

October 28, 2019

Last Update Submit

May 9, 2023

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

  • 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.

    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 (1)

  • 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.

Study Arms (2)

Verbal suggestion

OTHER
Behavioral: SuggestionsDevice: Deep brain stimulation

No suggestion

OTHER
Behavioral: SuggestionsDevice: Deep brain stimulation

Interventions

SuggestionsBEHAVIORAL

Verbal suggestions or no suggestions about treatment outcome

No suggestionVerbal suggestion
Deep brain stimulationDEVICE

Regulation of deep brain stimulation intensity

No suggestionVerbal suggestion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology and Behavioural Sciences, Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

SuggestionDeep Brain Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesElectric Stimulation TherapySurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

November 5, 2019

Study Start

December 1, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)