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

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ClinicalTrials.gov Identifier: NCT03820843
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Ischemic or Hemorrhagic Stroke Other: Art therapy and standard orthophonic rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes 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
Primary Purpose: Treatment
Official Title: Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Art therapy
Art therapy and standard orthophonic rehabilitation
Other: Art therapy and standard orthophonic rehabilitation
In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy

No Intervention: Control group
Only standard orthophonic rehabilitation



Primary Outcome Measures :
  1. change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks [ Time Frame: from inclusion at 6 weeks ]
  2. 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 Measures :
  1. change from baseline Aphasia at 6 weeks [ Time Frame: from inclusion at 6 weeks ]
    The BDAE (Boston Diagnostic Aphasia Examination) score ranges from 0 to 5, with higher values indicating more severe impairment

  2. change from baseline Aphasia at 6 weeks [ Time Frame: from inclusion at 6 weeks ]
    The ART (Aphasia Rapid Test) score ranges from 0 to 26, with higher values indicating more severe impairment

  3. change from baseline Anxiety and depression at 6 weeks [ Time Frame: from inclusion and 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

  4. change from baseline Quality of life self-assessment at 6 weeks [ Time Frame: from inclusion at 6 weeks ]
    Visual Analogic scale of patient quality of life is a 0% to 100% scale, with 100 indicating the best health status

  5. Satisfaction self-assessment at 6 weeks [ Time Frame: at 6 weeks only ]
    visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Severe motor deficiency (hemiplegia) on the segmental force scale
  • Mute patients, illiterate patients
  • Patients leaving the neurological SSR department prematurely
  • Patients not affiliated to a social security scheme
  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820843


Contacts
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Contact: Ahmed Bacha 0142161677 ahmed.bacha@aphp.fr
Contact: Anne Bissery 0142162432 anne.bissery@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Sophie Dupont Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03820843    
Other Study ID Numbers: APHP180312
N° IDRCB: 2018-A02462-53 ( Other Identifier: ANSM )
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
brain connectivity
aphasia
art therapy
rehabilitation
Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms