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临床试验/NCT06502496
NCT06502496尚未招募3 期

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

Fondation Ophtalmologique Adolphe de Rothschild0 个研究点目标入组 48 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
48
主要终点
changes in performance to obtain a reward (reward-based learning task) between before the sessions and 1 to 2 weeks after the sessions

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: art-therapy (Behavioral)

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.

干预措施: relaxation (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

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