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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151043
• Other study ID #: UAarhus_Sophie
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Parkinson Disease

Intervention

Behavioral:
• Suggestions
Verbal suggestions or no suggestions about treatment outcome

Device:
• Deep brain stimulation
Regulation of deep brain stimulation intensity

Locations

Country	Name	City	State
Denmark	Department of Psychology and Behavioural Sciences, Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	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.