Behavioural Study in Chronic Pain : Creativity and Motivation, and Circuits Involved in Functional MRI (AART)

Being creative means having the ability to produce ideas, actions or works that are original and different from what we have already done. This process involves mental flexibility, in particular the association of distant ideas or divergent thinking. This creative potential is complex and depends on a number of factors, both internal (personality, motivation, emotional state, stress) and external to the individual (socio-cultural context). The generation of creative ideas involves the fronto-striatal circuit, with a balance between flexibility and perseverance. The striatum is central to the reward system and mental flexibility, while the prefrontal cortex is involved in executive control, underpinning perseverance functions. Dopamine plays a key role in this balance, and changes in dopamine levels, depending on the type of receptor activated, will have a direct impact on the transition between mental flexibility and perseverance. Furthermore, in the context of chronic pain, changes in connectivity and activity can be observed in neuroimaging in these same regions of the reward circuit. This suggests that the dopaminergic system is also involved in the chronicisation of pain. The creative process would therefore be correlated with the dopaminergic reward system, involving several dimensions, both cognitive in terms of mental flexibility, coping strategies and perseverance, and motivational. In this context, art therapy treatments are beginning to be studied, particularly in patients suffering from Alzheimer's or Parkinson's disease, showing improvements in anxiety and depression.

Art therapy has not yet been widely proposed or studied for patients suffering from chronic pain. A more detailed behavioural study would confirm and clarify the clinical benefits for patients, by exploring the neuronal circuits involved, particularly the dopaminergic reward system.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged 18 and over
  • Consent to participate in the study
  • Available for protocol visits
  • Treated for chronic pain

Exclusion Criteria:

  • Progressive neurodegenerative neurological pathology impairing cognitive function
  • Untreated clinical depressive syndrome
  • Fibromyalgia in the foreground
  • High doses of opioid treatment (greater than 100 mg/d of morphine equivalent)
  • Impaired judgement or inability to receive information that prevents performance of behavioural tasks
  • Absolute contraindication to MRI (e.g. pacemaker and implantable stimulator not MRI compatible, intra-orbital metallic foreign body);
  • Persons benefiting from a legal protection measure
  • Pregnant or breast-feeding women
  • Patient deprived of liberty
  • Patient suffering from mental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: art-therapy
Art therapy workshops : groups of 6 to 12 patients supervised over a session of 1.5 to 2 hours, in the presence of an artist and the nursing staff (psychologist, nurse, doctor). There are 6 sessions per group, with an average of one week between sessions.
Over the 6 sessions, different artistic techniques will be explored, depending on the artist leading the workshop: stencil, graffiti, spray paint, collage, oil pastel, calligraphy and acrylic doodling. A collective work may also be proposed.
Active Comparator: relaxation
Relaxation workshops (control group): groups of 6 to 12 patients supervised over a session of 1.5 to 2 hours, in the presence of the psychologist. 5 sessions per group, with an average of one week between sessions.
relaxation sessions with the referent psychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in performance to obtain a reward (reward-based learning task) between before the sessions and 1 to 2 weeks after the sessions
Time Frame: Day0 and 1 to 2 weeks after the last session
the reward learning ability will be assessed using a specific task. The result of the task questionnaire is a numeric score.
Day0 and 1 to 2 weeks after the last session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBD_2023_8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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