Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Homonymous visual field defects (HVFDs) following acquired brain lesions affect independent living by hampering several activities of everyday life. Available treatments are intensive and week- or month-long. Transcranial Direct current stimulation (tDCS), a plasticity-modulating non-invasive technique, could be combined with behavioral trainings to boost their efficacy or reduce treatment duration. Some promising attempts have been made pairing occipital tDCS with visual restitution training, however less is knows about which area/network should be best stimulated in association with compensatory approaches, aimed at improving exploratory abilities, such as multisensory trainings.

In the present double-blind, sham-controlled study, we assess the efficacy of a multisensory training combined with tDCS. 3 groups of participants with chronic HVFDs underwent a 10-day (1.5 hrs/day) compensatory audio-visual training combined with either real anodal tDCS applied to the ipsilesional occipital tDCS (Group 1), or the ipsilesional posterior parietal cortex (Group 2), or a sham, placebo, tDCS (Group 3).

The training require the participants to orient their gaze training spatio-temporally congruent, cross-modal, audio-visual stimuli (starting from a central fixation) and press a button as quick as possible upon the detection of the visual stimulus. All stimuli are presented on 2mx2m panel embedded with 48 LEDs and loudspeakers (Bolognini et al., 2010, Brain Research)

All participants underwent a neuropsychological assessment of visuospatial functions prior to the beginning of the training (t0), at the end of the training (t1), and at 1-month (t2) and 4-month follow-up (t3). The assessment includes: a visual detection task, three visual search tasks (EF, Triangles, and Numbers; Bolognini et al., 2005, Brain), and a questionnaire about functional impact of the HVFDs in the activities of daily living.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Transcranial Direct Current Stimulation (TDCS) to Enhance the Rehabilitative Effect of Vision Restoration Therapy

NCT00921427

Hemianopia Quadrantanopia Scotoma +1 more

COMPLETED EARLY_PHASE1

Multisensory Telerehabilitation for Visual Field Defects

NCT06341777

Visual Field Defect Following Cerebrovascular Accident Hemianopia Brain Injuries

COMPLETED NA

tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia

NCT02956668

Hemianopsia

WITHDRAWN NA

Improving Visual Field Deficits With Noninvasive Brain Stimulation

NCT05085210

Visual Field Defect, Peripheral Stroke Visual Impairment +6 more

RECRUITING NA

Clinical Treatment of Transcranial Direct Current Stimulation in Older Adolescents With Amblyopia

NCT06760910

Amblyopia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Hemianopsia, Homonymous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups of participants were allocated to three different experimental treatments:

Group 1: audio-visual training + ipsilesional occipital tDCS Group 2: audio-visual training + ipsilesional posterior parietal tDCS Group 3: audio-visual training + sham, placebo tDCS

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The tDCS device has a built-in function for double blind studies, i.e., the experimenters are not aware whether they are applying real or sham tDCS.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anodal Occipital tDCS + audio-visual training

Anodal tDCS on ipsilesional occipital cortex. Anode electrode placed on O1/O2 (10-20 EEG system) and reference electrode placed on the contralateral forehead. Stimulation delivered at 2mA during the first 30 minutes of the audio-visual training.

Group Type EXPERIMENTAL

Anodal or sham tDCS

Intervention Type DEVICE

Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.

Audio-visual training

Intervention Type BEHAVIORAL

90 min/day x 10 days. Participants are seated in front of a 2 m × 2 m training board, at a distance of 1.2 m, in a dimly lit room. The board features 48 red light-emitting diodes (LED, diameter 1 cm, luminance 90 cd m2), distributed in six horizontal rows (eight lights per row). Forty-eight piezoelectric loudspeakers (0.4 W, 8Ω) are located above each light, producing a white-noise (80 dB, duration 100 ms).

Spatio-temporally congruent, cross-modal, audio-visual stimuli are presented at one out of 48 possible positions on the board. Participants are instructed to look at the fixation point - at the center of the apparatus - and to move their eyes to detect the presence of the visual stimulus (duration=100 ms) by pressing right button of a wireless mouse.

Anodal Parietal tDCS + audio-visual training

Anodal tDCS on ipsilesional posterior parietal cortex. Anode electrode placed on P3/P4 (10-20 EEG system) and reference electrode placed on the contralateral forehead. Stimulation delivered at 2mA during the first 30 minutes of the audio-visual training.

Group Type EXPERIMENTAL

Anodal or sham tDCS

Intervention Type DEVICE

Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.

Audio-visual training

Intervention Type BEHAVIORAL

90 min/day x 10 days. Participants are seated in front of a 2 m × 2 m training board, at a distance of 1.2 m, in a dimly lit room. The board features 48 red light-emitting diodes (LED, diameter 1 cm, luminance 90 cd m2), distributed in six horizontal rows (eight lights per row). Forty-eight piezoelectric loudspeakers (0.4 W, 8Ω) are located above each light, producing a white-noise (80 dB, duration 100 ms).

Spatio-temporally congruent, cross-modal, audio-visual stimuli are presented at one out of 48 possible positions on the board. Participants are instructed to look at the fixation point - at the center of the apparatus - and to move their eyes to detect the presence of the visual stimulus (duration=100 ms) by pressing right button of a wireless mouse.

Sham tDCS + audio-visual training

Arm 3: sham tDCS. Half of participants with Group 1 montage, the other half with Group 2 montage. Stimulator is turned off after 30s of the audio-visual training.

Group Type SHAM_COMPARATOR

Anodal or sham tDCS

Intervention Type DEVICE

Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.

Audio-visual training

Intervention Type BEHAVIORAL

90 min/day x 10 days. Participants are seated in front of a 2 m × 2 m training board, at a distance of 1.2 m, in a dimly lit room. The board features 48 red light-emitting diodes (LED, diameter 1 cm, luminance 90 cd m2), distributed in six horizontal rows (eight lights per row). Forty-eight piezoelectric loudspeakers (0.4 W, 8Ω) are located above each light, producing a white-noise (80 dB, duration 100 ms).

Spatio-temporally congruent, cross-modal, audio-visual stimuli are presented at one out of 48 possible positions on the board. Participants are instructed to look at the fixation point - at the center of the apparatus - and to move their eyes to detect the presence of the visual stimulus (duration=100 ms) by pressing right button of a wireless mouse.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anodal or sham tDCS

Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.

Intervention Type DEVICE

Audio-visual training

90 min/day x 10 days. Participants are seated in front of a 2 m × 2 m training board, at a distance of 1.2 m, in a dimly lit room. The board features 48 red light-emitting diodes (LED, diameter 1 cm, luminance 90 cd m2), distributed in six horizontal rows (eight lights per row). Forty-eight piezoelectric loudspeakers (0.4 W, 8Ω) are located above each light, producing a white-noise (80 dB, duration 100 ms).

Spatio-temporally congruent, cross-modal, audio-visual stimuli are presented at one out of 48 possible positions on the board. Participants are instructed to look at the fixation point - at the center of the apparatus - and to move their eyes to detect the presence of the visual stimulus (duration=100 ms) by pressing right button of a wireless mouse.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Presence of chronic (\>3 months) HVFD according to Neurophtalmological evaluation, due to acquired brain injury (i.e., stroke, traumatic brain injury, brain tumor)

Exclusion Criteria

* Presence of hemispatial neglect (indexed by pathological asymmetries on paper-and-pencil tests)
* Disorders of conjugated eye movements
* Other neurological disorders (e.g., dementia)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No