Clinical trial NCT03820843: Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia
Official title: Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic or Hemorrhagic Stroke
Keywords: brain connectivity
aphasia
art therapy
rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will evaluate 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.
Primary purpose: TREATMENT

Brief summary: A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
timeFrame: from inclusion at 6 weeks
measure: change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
timeFrame: from inclusion at 6 weeks
Secondary outcomes:
measure: change from baseline Aphasia at 6 weeks
timeFrame: from inclusion at 6 weeks
measure: change from baseline Aphasia at 6 weeks
timeFrame: from inclusion at 6 weeks
measure: change from baseline Anxiety and depression at 6 weeks
timeFrame: from inclusion and at 6 weeks
measure: change from baseline Quality of life self-assessment at 6 weeks
timeFrame: from inclusion at 6 weeks
measure: Satisfaction self-assessment at 6 weeks
timeFrame: at 6 weeks only
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sophie Dupont
role: PRINCIPAL_INVESTIGATOR
References: