Rehabilitation Methods for Unilateral Spatial Neglect in Stroke Patients

NCT06802159 | Recruiting

• 1 other identifier: NeglectRehab01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Unilateral Spatial Neglect (USN)

Keywords

Unilateral spatial neglect; stroke; rehabilitation; eye-tracking; computerized cognitive training

Outcome Measures

Primary Outcomes (1)

• Visual search for objects in the left and right hemifield among distractors

  The visual search task is aimed at determining the latent search time for subject images (soccer ball, blue suitcase, potatoes in a glass) among a large number of distractors. The test is also performed on a C-Eye II Pro. The test procedure starts with recalibration, with a total of 5 calibration points. The test utilizes the visual biofeedback function - the specialist and the subject can observe the gaze movement of the patient. At the Measurement compared to baseline after 2 weeks beginning of the test, the patient is asked to scrutinize the appeared picture (target and distractor images appear on the screen at the same time) for 30 seconds. After that, the patient should fix his or her gaze on the image of a white question mark in the center of the screen. Next, search tasks are given to find: soccer ball, red felt-tip pen, blue suitcase, green light bulb, planet earth, fries in a glass. The patient's task was to find all target objects in less than 25 seconds from a fixed point.

  Measurement compared to baseline after 2 weeks

Secondary Outcomes (4)

• Albert test

  Measurement compared to baseline after 2 weeks

• Bell's Test

  Measurement compared to baseline after 2 weeks

• Line bisection test

  Measurement compared to baseline after 2 weeks

• Test of complex competitive stimulation in both visual hemifields

  Measurement compared to baseline after 2 weeks

Study Arms (3)

Conventional group

ACTIVE COMPARATOR

Patients with prescribed traditional neuropsychological rehabilitation. The rehabilitation program consisted of 6-10 sessions. On average, one session lasted 25-30 minutes, which was also limited by inpatient conditions (no correctional sessions with a neuropsychologist longer than 30 minutes) and the patient's fatigue.

Behavioral: Conventional therapy

Eye tracker group

EXPERIMENTAL

Patients with assigned rehabilition to the alternative communication device - oculograph C Eye Pro (Assistech). The correctional program consisted of 6-10 sessions. On average, one session lasted 25-30 minutes, which was also limited by inpatient conditions (no correctional sessions with a neuropsychologist longer than 30 minutes) and patient fatigue.

Behavioral: Eye tracking based therapy

Cognitive training group

EXPERIMENTAL

Patients with assigned rehabilitation on the RehaCom modular therapy system (HASOMED GmbH;). The rehabilitation program consisted of 6-10 sessions. One session lasted 25-30 minutes, which was also limited by inpatient conditions (no correctional sessions with a neuropsychologist longer than 30 minutes) and the patient's fatigue.

Behavioral: Cognitive therapy

Interventions

Conventional therapy BEHAVIORAL

The methods of traditional neuropsychological rehabilitation used in the classes included: * attention tasks: proofreading tests, Schulte's Table; * spatial thinking tasks: copying, drawing, tasks using Nikitin cubes; * text reading tasks: texts from the Luria album. Each session began with oculomotor exercises. The correction programs differed by the type of feedback given to the patient in the course of correction. Feedback in this type of intervention is in the form of prompts from a specialist.

Conventional group

Eye tracking based therapy BEHAVIORAL

Rehabilitation in this group was carried out using an alternative communication device - oculograph C-Eye Pro (Assistech). The use of the device is characterized by a number of features: the presence of the eye movement biofeedback function (the patient and the specialist can see where the patient's gaze is directed by the movement of the red dot on the screen), the device needs to be pre-calibrated before the beginning of the session. To implement rehabilitation activities such tasks were used as: * Visual field training; * Word composing; * Vowel insertion; * Reading; * etc. The peculiarity of correction on the apparatus of alternative communication - oculograph - was the use of visual biological communication, visual biological communication, also in case of wrong answer a sound signal followed.

Eye tracker group

Cognitive therapy BEHAVIORAL

Rehabilitation of patients in the second experimental group was carried out on the RehaCom modular therapeutic system. The modular system includes a dedicated keyboard that has: numbers 1-9, 4 ok buttons, 4 arrow buttons, 2 pause/tip buttons and 2 exit/cancel buttons. Most of the tasks are performed using the keyboard, some of the tasks involved touch screen control. Tasks with stimulus images in the left screen space were used for rehabilitation activities: * "Saccades"; * "Attention and Concentration"; * "Planar Imagination"; * "General Presentation and Reading"; * "Shopping"; * "Daily routine". A feature of the correction on the modular therapy system was the involvement of a motor component, playing a sound cue or visual cue when an error occurred.

Cognitive training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health: lead

Study Sites (2)

Federal Center of Brain and Neurotechnologies of the FMBA of Russia

Moscow, Moscow, 117997, Russia

RECRUITING

Federal Center of Brain and Neurotechnologies of the FMBA of Russia

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Salima Eneeva

CONTACT

+79629155338; eneeva@fccps.ru

Marina Alekseevna, Dr

CONTACT

+79162283211; shurupova@fccps.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 9, 2025
• Primary Completion: June 15, 2025
• Study Completion: December 15, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)