- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820843
Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators will evaluate, at inclusion and at 6 weeks, the reorganization of functional and structural brain connectivity maps before and after rehabilitation of aphasia with art therapy and standard orthophonic rehabilitation versus a control group that received only standard orthophonic rehabilitation.
The investigators will include all consecutive patients with recent ischemic or hemorrhagic stroke with unilateral lesion(s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h.
All patients will undergo 2 MRI with tensor diffusion sequences (structural connectivity) and fMRI (functional magnetic resonance imaging) resting state sequences (functional connectivity) at inclusion and 6 weeks after rehabilitation with or without art therapy.
The investigators aimed to demonstrate that early activation of the right hemisphere related to the practice of the visual arts could facilitate the recovery of language in later strokes completely disrupting the language areas of the left hemisphere.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75013
- Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with recent ischemic or haemorrhagic stroke with unilateral lesion (s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h
- Post stroke delay of 15 days to 2 months
- Existence of moderate to severe phasic disorders on Aphasia Rapid Test score (ART, score> 6, scale of 26 items)
- Patient able to read and understand French
- Rightful
- Normal and corrected vision and hearing
- Absence of pre-existing degenerative neurological disorder
- Patient having signed his consent
- Age ≥ 18 years
Exclusion Criteria:
- Patients with contraindications to MRI or claustrophobic
- Patients under legal protection
- Patients with behavioral disorders or disabling neurovisual disorders making participation in art therapy impossible
- Mute patients, illiterate patients
- Patients leaving the neurological SSR department prematurely
- Patients not affiliated to a social security scheme
- Pregnant or lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Art therapy
Art therapy and standard orthophonic rehabilitation
|
In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy
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No Intervention: Control group
Only standard orthophonic rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
Time Frame: from inclusion at 6 weeks
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from inclusion at 6 weeks
|
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change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
Time Frame: from inclusion at 6 weeks
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from inclusion at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change from baseline Aphasia at 6 weeks
Time Frame: from inclusion at 6 weeks
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The BDAE (Boston Diagnostic Aphasia Examination) score ranges from 0 to 5, with higher values indicating more severe impairment
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from inclusion at 6 weeks
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change from baseline Aphasia at 6 weeks
Time Frame: from inclusion at 6 weeks
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The ART (Aphasia Rapid Test) score ranges from 0 to 26, with higher values indicating more severe impairment
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from inclusion at 6 weeks
|
|
change from baseline Anxiety and depression at 6 weeks
Time Frame: from inclusion and at 6 weeks
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The HADS (Hospital Anxiety and Depression Scale) scores ranges from 0 to 21 for both anxiety and depression scores, with higher values indicating more severe impairment
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from inclusion and at 6 weeks
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change from baseline Quality of life self-assessment at 6 weeks
Time Frame: from inclusion at 6 weeks
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Visual Analogic scale of patient quality of life is a 0% to 100% scale, with 100 indicating the best health status
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from inclusion at 6 weeks
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Satisfaction self-assessment at 6 weeks
Time Frame: at 6 weeks only
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visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction
|
at 6 weeks only
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sophie Dupont, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neurobehavioral Manifestations
- Stroke
- Communication Disorders
- Language Disorders
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemorrhagic Stroke
- Ischemia
- Aphasia
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Art Therapy
Other Study ID Numbers
- APHP180312
- N° IDRCB: 2018-A02462-53 (Other Identifier: ANSM)
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
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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