tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia

NCT02956668 | Withdrawn DMC

• 1 other identifier: 264-BSTDCS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Homonymous hemianopia is one of the most common symptoms following a neurologic damage and has many negative effects on functional abilities and daily activities. There are two main kind of restorative rehabilitation of hemianopia: "border training", which involves exercising vision at the edge of the damaged visual field, and "blindsight training", which is based on exercising the unconscious perceptual functions in the mild of the blind hemifield. In literature only border training effects were shown to be facilitated by transcranial direct current stimulation (tDCS). The investigators treat two patients with blindsight rehabilitation associated to tDCS over parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment associated to tDCS and a cycle of blindsight training alone in inverted order. Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance the improvement induced by blindsight rehabilitation treatment.

Conditions

Hemianopsia

Keywords

tDCS; Visual field; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Humphrey visual field 30.2 SITA standard test

  10 weeks and 20 weeks

Secondary Outcomes (3)

• Change in Battery for Attentional Performance (TAP) subtest: Visual Field

  10 weeks and 20 weeks

• International Classification of Functioning (ICF)

  20 weeks

• Change in Schuhfried Vienna Test Peripheral Perception (PP-R)

  10 weeks and 20 weeks

Study Arms (2)

Blindsight training associated to tDCS

EXPERIMENTAL

During the blindsight training (one-hour time), the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli. During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time. tDCS stimulation start at the beginning of the rehabilitation session, and continue for 30 min, during treatment. Anode is placed over the parieto-occipital cortex. The cathode is placed in the contralateral supraorbital position.

Other: Blindsight Training associated to tDCS

Blindsight training alone

ACTIVE COMPARATOR

During the blindsight training (one-hour time), the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli. During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time.

Other: Blindsight Training alone

Interventions

Blindsight Training associated to tDCS OTHER

The patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS.

Blindsight training associated to tDCS

Blindsight Training alone OTHER

The patient undergo visual rehabilitation

Blindsight training alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is able to give his informed consent
• Stroke
• Hemianopsia brain damage documented by means of TAC or RMN
• Hemianopsia diagnosed by means automated visual field and Neurological Evaluation
• Time from lesion at least six months
• normal or corrected-to-normal visual acuity

You may not qualify if:

• Presence of Ophthalmologic neuropsychologic or psychiatric pathology
• Global cognitive deficit,
• Presence of other neurological pathology
• Presence of cardiac peacemaker
• Presence metallic or electronic items in the head or in the body
• Story/familiarity of epilepsy, taking medications that can induce epileptic crisis
• Severe heart disease
• History of high alcohol consumption
• Pregnancy

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Polo universitario presso I.C. Zucchi

Carate Brianza, CB, 20841, Italy

Location

MeSH Terms

Conditions

Hemianopsia; Stroke

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Barbara M Matteo

  Università degli Studi di Milano - Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 7, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

IT (1)