Ischemic or Hemorrhagic StrokeART-CONNECTNCT03820843
Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia
A study testing Art therapy and standard orthophonic rehabilitation in people with Ischemic or Hemorrhagic Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic or Hemorrhagic Stroke
- What is being tested?
- Art therapy and standard orthophonic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2020to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Absence of pre-existing degenerative neurological disorder
- Patient having signed his consent
- Age ≥ 18 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation
Paris, 75013
About this study
Official title: Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
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.
Read the 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.
- Conditions
- Ischemic or Hemorrhagic Stroke
- Being tested
- Art therapy and standard orthophonic rehabilitation
- Keywords
- brain connectivity, aphasia, art therapy, rehabilitation
- Medical subject headings
- Ischemia, Hemorrhagic Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapy and standard orthophonic rehabilitationOther
In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy
| Study group | Role | What they receive |
|---|---|---|
| Art therapy | Experimental | Art therapy and standard orthophonic rehabilitation Receives: Other: Art therapy and standard orthophonic rehabilitation |
| Control group | No intervention | Only standard orthophonic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
Measured: from inclusion at 6 weeks
change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
Measured: from inclusion at 6 weeks
Secondary outcomes (5)
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
Measured: from inclusion at 6 weeks
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
Measured: from inclusion at 6 weeks
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
Measured: from inclusion and at 6 weeks
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
Measured: from inclusion at 6 weeks
Satisfaction self-assessment at 6 weeks
visual analogic scale of patient satisfaction is a 0 to 10 scale, with higher values indicating better satisfaction
Measured: at 6 weeks only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start17 Feb 2020
- Primary completion16 Dec 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic or Hemorrhagic StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Dupont, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820843
- Sponsor's protocol ID
- APHP180312
- Other IDs
- N° IDRCB: 2018-A02462-53
- Acronym
- ART-CONNECT
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2019
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
- ClinicalTrials.gov ID
- NCT03820843
- Acronym / sponsor ID
- ART-CONNECT / APHP180312
- Conditions
- Ischemic or Hemorrhagic Stroke
- Keywords
- brain connectivity, aphasia, art therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Art therapy | Experimental | Other: Art therapy and standard orthophonic rehabilitationArt therapy and standard orthophonic rehabilitation |
| Control group | No intervention | –Only standard orthophonic rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art therapy and standard orthophonic rehabilitationIn addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy | Other | Art therapy |
Primary outcome
change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
Time frame: from inclusion at 6 weeks
change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
Time frame: from inclusion at 6 weeks
5 secondary outcomes
change from baseline Aphasia at 6 weeks
Time frame: from inclusion at 6 weeks
change from baseline Aphasia at 6 weeks
Time frame: from inclusion at 6 weeks
change from baseline Anxiety and depression at 6 weeks
Time frame: from inclusion and at 6 weeks
change from baseline Quality of life self-assessment at 6 weeks
Time frame: from inclusion at 6 weeks
Satisfaction self-assessment at 6 weeks
Time frame: at 6 weeks only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Dupont principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy and standard orthophonic rehabilitation in people with Ischemic or Hemorrhagic Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks (time frame: from inclusion at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.