Prismatic Lenses and tDCS in Neglect
September 1, 2025 updated by: Simona Spaccavento, 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
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 Contact
- Name: Simona Spaccavento
- Phone Number: +393332783524
- Email: simona.spaccavento@icsmaugeri.it
Study Locations
-
-
Ba
-
Bari, Ba, Italy, 70025
- Recruiting
- Istituti Clinici Scientifici Maugeri
-
Contact:
- Simona Spaccavento
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
|
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
|
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 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
|
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Estimated)
July 15, 2026
Study Completion (Estimated)
December 31, 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 (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 1, 2025
Last Verified
September 1, 2025
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
product manufactured in and exported from the U.S.
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.