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NCT Number: NCT05842551

Prismatic Lenses and tDCS in Neglect

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Scientifici Maugeri

Bari, Ba, 70025, Italy

Location status: Recruiting

Location contact

Simona Spaccavento

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prismatic adaptation and electric stimulation

Combination Product

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

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. Neuropsychological outcome

    Time frame: Change from baseline the Bergegò Scale at 2 weeks.

    Bergegò Scale (0-30); high score means a better outcome

  5. Functional outcome

    Time frame: Change from baseline the Barthel Index at 2 weeks

    Barthel Index (0-100); high score means a better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Simona Spaccavento

CONTACT

[email protected]

+393332783524

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • Azienda USL Toscana Sud Est

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 6, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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