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

Primary Purpose

Ischemic or Hemorrhagic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Art therapy and standard orthophonic rehabilitation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic or Hemorrhagic Stroke focused on measuring brain connectivity, aphasia, art therapy, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et RéadaptationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Art therapy

Control group

Arm Description

Art therapy and standard orthophonic rehabilitation

Only standard orthophonic rehabilitation

Outcomes

Primary Outcome Measures

change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks

Secondary Outcome Measures

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
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
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
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
Satisfaction self-assessment at 6 weeks
visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction

Full Information

First Posted
January 10, 2019
Last Updated
January 24, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03820843
Brief Title
Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia
Acronym
ART-CONNECT
Official Title
Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
February 2, 2022 (Anticipated)
Study Completion Date
February 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic or Hemorrhagic Stroke
Keywords
brain connectivity, aphasia, art therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Single-blind: only the art therapist knows the randomization arm. The investigators involved in the outcomes assessement, will remain blinded with regard to the randomized treatment assignments
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Art therapy
Arm Type
Experimental
Arm Description
Art therapy and standard orthophonic rehabilitation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Only standard orthophonic rehabilitation
Intervention Type
Other
Intervention Name(s)
Art therapy and standard orthophonic rehabilitation
Intervention Description
In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy
Primary Outcome Measure Information:
Title
change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
Time Frame
from inclusion at 6 weeks
Title
change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
Time Frame
from inclusion at 6 weeks
Secondary Outcome Measure Information:
Title
change from baseline Aphasia at 6 weeks
Description
The BDAE (Boston Diagnostic Aphasia Examination) score ranges from 0 to 5, with higher values indicating more severe impairment
Time Frame
from inclusion at 6 weeks
Title
change from baseline Aphasia at 6 weeks
Description
The ART (Aphasia Rapid Test) score ranges from 0 to 26, with higher values indicating more severe impairment
Time Frame
from inclusion at 6 weeks
Title
change from baseline Anxiety and depression at 6 weeks
Description
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
Time Frame
from inclusion and at 6 weeks
Title
change from baseline Quality of life self-assessment at 6 weeks
Description
Visual Analogic scale of patient quality of life is a 0% to 100% scale, with 100 indicating the best health status
Time Frame
from inclusion at 6 weeks
Title
Satisfaction self-assessment at 6 weeks
Description
visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction
Time Frame
at 6 weeks only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Dupont
Phone
0142160301
Email
sophie.dupont@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Bissery
Phone
0142162432
Email
anne.bissery@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Dupont
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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