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

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University of Aarhus

Status

Completed

Conditions

Pain

Treatments

Device: Deep brain stimulation
Behavioral: Suggestions

Study type

Interventional

Funder types

Other

Identifiers

NCT04151043
UAarhus_Sophie

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 2 patient groups

Verbal suggestion
Other group
Treatment:
Behavioral: Suggestions
Device: Deep brain stimulation
No suggestion
Other group
Treatment:
Behavioral: Suggestions
Device: Deep brain stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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