- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06502496
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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