Prismatic Lenses and tDCS in Neglect

November 5, 2026 updated by: Istituti Clinici Scientifici Maugeri SpA

The Effect of Prismatic Lenses in Association With tDCS in Patients With Neglect: a Pilot Study

The goal of this study is to to evaluate the effect and feasibility of a rehabilitation protocol with prismatic lenses associated with tDCS, compared to a prismatic lens rehabilitation protocol associated with sham stimulation, in reducing the signs of neglect in a group of patients with spatial heminegligence following ischemic stroke of the right hemisphere.

The secondary objective is to evaluate the impact of this rehabilitation protocol on functional outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ba
      • Bari, Ba, Italy, 70025
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age >18 years
  • ischemic stroke
  • hospitalization within 90 days of the event

Exclusion Criteria:

  • heamorrhagic stroke
  • history of neurological disease
  • history of psychiatric disease
  • use of alchool and drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

Patients will receive anodic tEs combined with prismatic lenses for two weeks
Combination product: Prismatic adaptation and electric stimulation

Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group
Sham Comparator: Control

Patients will receive sham tEs combined with prismatic lenses for two weeks
Combination product: Prismatic adaptation and electric stimulation

Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological outcome
Time Frame: Change from baseline OCS at 2 weeks

Oxford Cognitive Screening (OCS): is structured in 10 subtests: picture naming (0-4); semantics (0-3); orientation (0-4); visual field (0-4); sentence reading (0-15); number writing (0-3); calculation (0-4); broken hearts (0-50); praxis (0-12); recall and recognition (0-4); trails task (0-13)
Change from baseline OCS at 2 weeks
Neuropsychological outcome
Time Frame: Change form baseline the semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks

The semi structured scale for the functional evaluation of extrapersonal neglect (0-9); high score means a worse outcome
Change form baseline the semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks
Neuropsychological outcome
Time Frame: Change form baseline the semi structured scale for the functional evaluation of personal neglect at 2 weeks

The semi structured scale for the functional evaluation of personal neglect (0-9); high score means worse outcome
Change form baseline the semi structured scale for the functional evaluation of personal neglect at 2 weeks
Neuropsychological outcome
Time Frame: Change from baseline the Bergegò Scale at 2 weeks.

Bergegò Scale (0-30); high score means a better outcome
Change from baseline the Bergegò Scale at 2 weeks.
Functional outcome
Time Frame: Change from baseline the Barthel Index at 2 weeks

Barthel Index (0-100); high score means a better outcome
Change from baseline the Barthel Index at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Azienda USL Toscana Sud Est

Investigators

  • Principal Investigator: Simona Spaccavento, Istituti Clinici Scientifici Maugeri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

July 15, 2026

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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