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

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ClinicalTrials.gov Identifier: NCT04151043
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pain Behavioral: Suggestions Device: Deep brain stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Analgesic Effects of Expectation and Deep Brain Stimulation in Patients With Parkinson's Disease
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Verbal suggestion Behavioral: Suggestions
Verbal suggestions or no suggestions about treatment outcome

Device: Deep brain stimulation
Regulation of deep brain stimulation intensity

No suggestion Behavioral: Suggestions
Verbal suggestions or no suggestions about treatment outcome

Device: Deep brain stimulation
Regulation of deep brain stimulation intensity




Primary Outcome Measures :
  1. Numerical rating scale (NRS) (Change) [ 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. ]
    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.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151043


Contacts
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Contact: Sophie W. Kjær, MSc +4560474341 swk@psy.au.dk

Locations
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Denmark
Department of Psychology and Behavioural Sciences, Aarhus University Recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04151043     History of Changes
Other Study ID Numbers: UAarhus_Sophie
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs