Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia

Ischemic or Hemorrhagic Stroke Clinical Trial

— ART-CONNECT  

Official title:

Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820843
• Other study ID #: APHP180312
• Secondary ID: N° IDRCB: 2018-A
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sophie Dupont
• Phone: 0142160301
• Email: sophie.dupont[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: December 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Hemorrhagic Stroke
• Ischemic or Hemorrhagic Stroke
• Stroke

Intervention

Other:
• Art therapy and standard orthophonic rehabilitation
In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks		from inclusion at 6 weeks
Primary	change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks		from inclusion at 6 weeks
Secondary	change from baseline Aphasia at 6 weeks	The BDAE (Boston Diagnostic Aphasia Examination) score ranges from 0 to 5, with higher values indicating more severe impairment	from inclusion at 6 weeks
Secondary	change from baseline Aphasia at 6 weeks	The ART (Aphasia Rapid Test) score ranges from 0 to 26, with higher values indicating more severe impairment	from inclusion at 6 weeks
Secondary	change from baseline Anxiety and depression at 6 weeks	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	from inclusion and at 6 weeks
Secondary	change from baseline Quality of life self-assessment at 6 weeks	Visual Analogic scale of patient quality of life is a 0% to 100% scale, with 100 indicating the best health status	from inclusion at 6 weeks
Secondary	Satisfaction self-assessment at 6 weeks	visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction	at 6 weeks only