search
Back to results

Prismatic Lenses and tDCS in Neglect

Primary Purpose

Stroke, Ischemic

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Prismatic adaptation and electric stimulation
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring stroke, neglect, tDCS, prismatic lenses

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituti Clinici Scientifici MaugeriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Control

Arm Description

Patients will receive anodic tEs combined with prismatic lenses for two weeks

Patients will receive sham tEs combined with prismatic lenses for two weeks

Outcomes

Primary Outcome Measures

Neuropsychological outcome
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)
Neuropsychological outcome
The semi structured scale for the functional evaluation of extrapersonal neglect (0-9); high score means a worse outcome
Neuropsychological outcome
The semi structured scale for the functional evaluation of personal neglect (0-9); high score means worse outcome
Neuropsychological outcome
Bergegò Scale (0-30); high score means a better outcome
Functional outcome
Barthel Index (0-100); high score means a better outcome

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
May 23, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Azienda USL Toscana Sud Est
search

1. Study Identification

Unique Protocol Identification Number
NCT05842551
Brief Title
Prismatic Lenses and tDCS in Neglect
Official Title
The Effect of Prismatic Lenses in Association With tDCS in Patients With Neglect: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Azienda USL Toscana Sud Est

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
stroke, neglect, tDCS, prismatic lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will receive anodic tEs combined with prismatic lenses for two weeks
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients will receive sham tEs combined with prismatic lenses for two weeks
Intervention Type
Combination Product
Intervention Name(s)
Prismatic adaptation and electric stimulation
Intervention Description
Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group
Primary Outcome Measure Information:
Title
Neuropsychological outcome
Description
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)
Time Frame
Change from baseline OCS at 2 weeks
Title
Neuropsychological outcome
Description
The semi structured scale for the functional evaluation of extrapersonal neglect (0-9); high score means a worse outcome
Time Frame
Change form baseline the semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks
Title
Neuropsychological outcome
Description
The semi structured scale for the functional evaluation of personal neglect (0-9); high score means worse outcome
Time Frame
Change form baseline the semi structured scale for the functional evaluation of personal neglect at 2 weeks
Title
Neuropsychological outcome
Description
Bergegò Scale (0-30); high score means a better outcome
Time Frame
Change from baseline the Bergegò Scale at 2 weeks.
Title
Functional outcome
Description
Barthel Index (0-100); high score means a better outcome
Time Frame
Change from baseline the Barthel Index at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Spaccavento
Phone
+393332783524
Email
simona.spaccavento@icsmaugeri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Spaccavento
Organizational Affiliation
Istituti Clinici Scientifici Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituti Clinici Scientifici Maugeri
City
Bari
State/Province
Ba
ZIP/Postal Code
70025
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Spaccavento

12. IPD Sharing Statement

Learn more about this trial

Prismatic Lenses and tDCS in Neglect

We'll reach out to this number within 24 hrs