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Prismatic Lenses and tDCS in Neglect

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05842551
Enrollment
30
Registered
2023-05-06
Start date
2023-03-07
Completion date
2026-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

Keywords

stroke, neglect, tDCS, prismatic lenses

Brief summary

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.

Interventions

COMBINATION_PRODUCTPrismatic 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

Sponsors

Azienda USL Toscana Sud Est
CollaboratorOTHER_GOV
Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional outcomeChange from baseline the Barthel Index at 2 weeksBarthel Index (0-100); high score means a better outcome
Neuropsychological outcomeChange from baseline OCS at 2 weeksOxford 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)

Countries

Italy

Contacts

Primary ContactSimona Spaccavento
simona.spaccavento@icsmaugeri.it+393332783524

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026