NCT04259203

Brief Summary

This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

4 active sites

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

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
Last Updated

December 5, 2025

Status Verified

May 1, 2022

Enrollment Period

4 years

First QC Date

February 4, 2020

Last Update Submit

December 4, 2025

Conditions

Parkinson DiseaseChronic Pain

Keywords

No-motor symptomsPain perceptionQuality of lifeHypnosisAuto-hypnosis

Outcome Measures

Primary Outcomes (1)

  • Change of the intensity of pain perception

    Measure of the intensity of pain perception by VAS at the baseline visit and at the post-treatment visit (2 months later). The difference between both values will allow to calculate a variation index.

    At baseline and 2 months after

Secondary Outcomes (10)

  • Change of the score at the Brief Pain Inventory

    At baseline and 2 months after

  • Change of the score at the McGill Pain Questionnaire

    At baseline and 2 months after

  • Change of the score at the Beck Depression Inventory

    At baseline and 2 months after

  • Change of the score at the Fatigue Severity Scale

    At baseline and 2 months after

  • Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)

    At baseline and 2 months after

  • +5 more secondary outcomes

Study Arms (2)

Erickson hypnosis

EXPERIMENTAL

5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.

Behavioral: Erickson hypnosis

Usual care

NO INTERVENTION

Usual management of pain symptoms

Interventions

Erickson hypnosisBEHAVIORAL

Erickson hypnosis sessions performed by an experienced hypnotherapist, according to a pre-established protocol : 5 sessions (1 per week). Between each session : exercise of auto-hypnosis by the patient himself, at home

Erickson hypnosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women
  • to 80 years old
  • idiopathic Parkinson's disease
  • without neurological co-morbidity
  • Suffering from chronic pain (for at least 3 months), related to Parkinson's disease
  • Having a pain intensity of at least 30 mm on the VAS (average intensity over the previous week) for Parkinson's disease-related pain
  • antiparkinsonian, analgesic and psychotropic treatments stable for 1-month
  • having a health insurance
  • signed informed consent form

You may not qualify if:

  • Patient with a neurological condition other than Parkinson's disease or with an atypical Parkinson's syndrome
  • Early untreated patient
  • Patient with acute intercurrent pain
  • Patient whose pain is mainly attributable to another pathology (rheumatoid arthritis, spondyloarthritis ankylosing, diabetic neuropathy, cancer, etc.)
  • Patient with cognitive impairment objectified by a score at the Montreal Cognitive Assessment (MoCA) \<24
  • Patient with hallucinations and/or psychosis (MDS-UPDRS 1.2\> 1)
  • Patient with a apathy (MDS-UPDRS 1.5\> 1)
  • Patient with disabling dyskinesia (MDS-UPDRS) 4.1 AND 4.2\> 1)
  • Patient under the protection of adults
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chu Cote de Nacre

Caen, France

Location

Hôpital Roger Salengro, CHRU de Lille

Lille, 59800, France

Location

Hopital Charles Nicolle Chu Rouen

Rouen, France

Location

Hopital Purpan Chu Toulouse

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Parkinson DiseaseChronic Pain

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luc Defebvre, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

August 8, 2020

Primary Completion

August 16, 2024

Study Completion

August 16, 2024

Last Updated

December 5, 2025

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)