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

NCT06502496 | Not Yet Recruiting Phase 3

• 1 other identifier: HBD_2023_8
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• changes in performance to obtain a reward (reward-based learning task) between before the sessions and 1 to 2 weeks after the sessions

  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

Study Arms (2)

art-therapy

EXPERIMENTAL

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.

Behavioral: art-therapy

relaxation

ACTIVE COMPARATOR

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.

Behavioral: relaxation

Interventions

art-therapy BEHAVIORAL

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.

art-therapy

relaxation BEHAVIORAL

relaxation sessions with the referent psychologist

relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In order to limit biases linked to the absence of blinding and to potential patient preferences for one or other of the interventions, a "consent to postponed information" type of consent (Boter et al. 2003) will be used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share