Clinical trial NCT06078111: Neglect Treatment by Prism Adaptation in the Acute Phase
Official title: Neglect Treatment by Prism Adaptation in the Acute Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unilateral Spatial Neglect
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. This syndrome, frequent and very invalidating for daily life activities after a brain damage, is a cognitive disorder of lack of attention towards a part of the space. Patients at a first event brain injury hospitalized into the Neurology and Neurosurgery Departments and affected by spatial neglect will undergo to a protocol of five consecutive rehabilitation treatments, being assigned to the experimental (prisms) or control groups (neutral prisms). The effectiveness of the treatment will be assessed with cognitive, functional and motor-related measures, as well as a follow up 3 months later. These results can have a strong impact on the long-term functional outcome of these patients.


Eligibility criteria: Inclusion Criteria:

* First neurological event, affecting the right hemisphere or the left hemisphere (stroke, brain tumour post-surgery);
* Structural images of the brain lesion available (magnetic resonance or tomographic scans);
* Good Normal (or corrected) visual acuity;
* Presence of USN, as assessed by a standard neuropsychological evaluation.

Exclusion Criteria:

* Previous neurological disorder and/or current or previous psychiatric disease.
* Presence or suspicion of previous general cognitive deficits documented from the clinical dossier and/or suspicious of possible cognitive deficits ;
* Presence of difficulty in task's comprehension preventing its completion;
* Impossibility to sustain a research session of at least 30 minutes (e.g., attentional lability).

Primary outcomes:
measure: Unilateral spatial neglect
timeFrame: Day 0; Day 5; 12 weeks after the end of the protocol
measure: Functional measures
timeFrame: Day 0; Day 5; 12 weeks after the end of the protocol
measure: Disability measures
timeFrame: Day 0; Day 5; 12 weeks after the end of the protocol
measure: Balance
timeFrame: Day 0; Day 5; 12 weeks after the end of the protocol
Secondary outcomes:
measure: Neuropsychological tests: Right vs. Left neglect
timeFrame: Day 5; 12 weeks after the end of the protocol
measure: Functional Measures: Right vs. Left neglect
timeFrame: Day 5; 12 weeks after the end of the protocol
measure: Disability Measures: Right vs. Left neglect
timeFrame: Day 5; 12 weeks after the end of the protocol
measure: Balance: Right vs. Left neglect
timeFrame: Day 5; 12 weeks after the end of the protocol
measure: Functional Measures: Follow-up
timeFrame: 12 weeks after the end of the protocol
measure: Balance: Follow-up
timeFrame: 12 weeks after the end of the protocol
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
state: Genf
Study officials:
References: