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

NCT ID: NCT06502496

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

art-therapy

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

relaxation

Intervention Type BEHAVIORAL

relaxation sessions with the referent psychologist

Interventions

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art-therapy

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.

Intervention Type BEHAVIORAL

relaxation

relaxation sessions with the referent psychologist

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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HBD_2023_8

Identifier Type: -

Identifier Source: org_study_id

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