Clinical trial NCT06802159: Rehabilitation Methods for Unilateral Spatial Neglect in Stroke Patients
Official title: A Comparative Analysis of Methods for Rehabilitation of Unilateral Spatial Neglect (USN) in Stroke Patients: Conventional Therapy, Computerized Cognitive Training and Eye Movement Biofeedback Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unilateral Spatial Neglect (USN)
Keywords: Unilateral spatial neglect
stroke
rehabilitation
eye-tracking
computerized cognitive training
Lead sponsor: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke remains one of the leading causes of mortality and disability worldwide. Between 30% and 40% of patients who have had an acute cerebral hemorrhage, develop unilateral spatial neglect syndrome (USN).

USN is observed in 24% of patients with left-hemispheric stroke and 45% of patients with right-hemispheric lesions in the acute phase acute phase and in 20% of patients in the chronic phase.

The presence of USN significantly complicates the rehabilitation process and negatively affects the functional outcomes. The complexity of USN correction is due to the heterogeneity of its manifestations and combination with other cognitive disorders. In 30-50% of patients with USN anosognosia is observed, in 60% - memory and attention disorders.

Traditional methods of rehabilitation lead to significant improvement in 30-50% of patients with USN. The use of combined methods of treatment, including pharmacotherapy and non-medication methods, can improve efficacy by up to 70-80%. This indicates the need to develop and investigate new approaches to correct USN.

Despite the growing number of studies in this area, there is still no unified approach to selecting the optimal method of USN correction for each individual patient.

Different methods of rehabilitation may have different effects on neuroplasticity processes, which opens new perspectives for optimization of rehabilitation strategies.

Detailed description: Stroke remain one of the leading causes of death and disability worldwide. According to the World Health Organization, about 15 million cases of stroke are registered annually, of which 5 million are fatal and another 5 million result in permanent disability.

In Russia, about 450 thousand cases of stroke are registered annually, with a mortality rate of about 35% during the first year after stroke. The frequency of ischemic strokes is 80-85%, hemorrhagic strokes - 15-20%.

According to the localization of the lesion, strokes in the middle cerebral artery basin are the most common (up to 50-60% of cases), followed by strokes in the vertebrobasilar basin (20-25%) and the anterior cerebral artery basin (10-15%).

Disability after a stroke is observed in 70-80% of surviving patients, with about 20-30% requiring constant nursing care.

Neuro-ophthalmologic disorders develop in 40-60% of cases in patients who have undergone stroke, while sensory inattention develops in 30-40% of cases. Sensory inattention, or neglect syndrome, is a manifestation of optic-spatial gnostic disorders.

In a systematic review analyzing the incidence of neglect syndrome after stroke, Esposito et al. reported that the syndrome occurs in 24%-with left hemispheric brain damage and 45% of patients with right hemispheric brain damage in the acute phase and in 20% 5 of patients in the chronic phase, but the prevalence of neglect syndrome varies between studies (up to 82%).

The scientific relevance of the study on the topic " A Comparative Analysis of Methods for Rehabilitation of Unilateral Spatial Neglect (USN) in Stroke Patients: Conventional Therapy, Computerized Cognitive Training and Eye Movement Biofeedback Training" is due to the high prevalence and significant impact of this syndrome on the rehabilitation process and quality of life of patients after stroke.

Unilateral spatial neglect (USN) is one of the most frequent and disabling syndromes in stroke, especially when the right hemisphere is affected. According to various studies, the prevalence of USN among stroke patients ranges from 13% to 81%. This wide range is due to differences in diagnostic methods and timing of evaluation after stroke. In the acute phase (first 2 weeks), USN is observed in 85% of patients with right hemispheric stroke, and 3 months after stroke, symptoms persist in 36% of patients.

The presence of USN significantly complicates the rehabilitation process and negatively affects functional outcomes. Studies show that patients with USN have a longer hospitalization period (28 days longer on average) compared to patients without USN. In addition, patients with USN are 20-40% less likely to achieve independence in activities of daily living. This leads to a significant increase in the economic burden: the presence of USN increases the cost of care for a patient after stroke by 25-40%.

The complexity of USN correction is due to the heterogeneity of its manifestations and its frequent combination with other cognitive disorders. Anosognosia (denial of their disease) is observed in 30-50% of patients with USN, and about 60% of patients have concomitant disorders of memory and attention. These factors make it difficult to involve patients in the rehabilitation process and require an individualized approach to the choice of correction methods.

Traditional rehabilitation methods lead to meaningful improvement in 30-50% of patients with USN. However, the use of combined treatment methods, including pharmacotherapy and non-medication methods, can increase the effectiveness to 70-80%. This indicates the need for the development and research of new approaches to the correction of USN.

In recent years, innovative methods for the correction of USN, such as the use of virtual reality and noninvasive brain stimulation, have been actively developed. The use of virtual reality can significantly improve the rehabilitation outcomes of patients with USN.

Currently, computerized training methods are very popular for improving cognitive functions, which include many tasks in various domains: memory, attention, perception, thinking, executive functions, etc. Similar computer solutions, for example RehaCom, can also be used to rehabilitate USN. In addition to the above functions, tasks in this software include training of visual functions, including scanning of affected visual fields, etc. On the other hand, it is extremely promising to use the method of training eye movements to study the affected hemifield in patients with USN. To provide biological feedback, this training uses the eye tracking method. This is a non-invasive method that allows even patients with paresis to work with rehabilitation equipment.

However, despite the growing number of studies in this area, there is still no unified approach to selecting the optimal method of USN correction for each specific patient. Existing studies often have methodological limitations and insufficient statistical power, which makes it difficult to formulate unambiguous recommendations.

In addition, most studies focus on the short-term effects of rehabilitation, whereas data on long-term outcomes are limited. According to some estimates, in 10-15% of patients with USN, symptoms persist for more than a year after stroke, which emphasizes the need to study the long-term effects of different methods of correction.

The relevance of comparative analysis of methods of USN correction is also due to the growing understanding of brain neuroplasticity and its role in stroke recovery. Studies show that different rehabilitation methods can differentially affect neuroplasticity processes, which opens new perspectives for optimizing rehabilitation strategies.

Finally, it is important to note that USN is often combined with other post-stroke disorders such as aphasia, apraxia and motor disorders. This requires an integrated approach to rehabilitation and the study of the interaction of different methods of correction.

Thus, the scientific relevance of the comparative analysis of methods of correction of USN in patients with stroke is due to the high prevalence of the syndrome, its significant impact on the rehabilitation process and quality of life of patients, as well as the need to develop more effective and personalized approaches to treatment. Such a study can make a significant contribution to the optimization of rehabilitation strategies and improvement of functional outcomes in patients with post-stroke USN.

Eligibility criteria: Inclusion Criteria:

* Normal cognitive development in accordance with age and educational level;
* diagnosis with codes I63, I61 (ICD);
* presence of unilateral spatial neglect syndrome in the neuropsychological status.

Exclusion Criteria:

* presence of mental and somatic pathology of severe degree and in decompensation stage;
* the presence of gross oculomotor disorders;
* presence of a sensory visual defect of moderate to severe severity

Primary outcomes:
measure: Visual search for objects in the left and right hemifield among distractors
timeFrame: Measurement compared to baseline after 2 weeks
Secondary outcomes:
measure: Albert test
timeFrame: Measurement compared to baseline after 2 weeks
measure: Bell's Test
timeFrame: Measurement compared to baseline after 2 weeks
measure: Line bisection test
timeFrame: Measurement compared to baseline after 2 weeks
measure: Test of complex competitive stimulation in both visual hemifields
timeFrame: Measurement compared to baseline after 2 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Center of Brain and Neurotechnologies of the FMBA of Russia
city: Moscow
country: Russian Federation
facility: Federal Center of Brain and Neurotechnologies of the FMBA of Russia
Study officials:
References: