Prismatic Lenses and tDCS in Neglect

Sponsor

Istituti Clinici Scientifici Maugeri SpA (Other)

Overall Status

Recruiting

CT.gov ID

NCT05842551

Collaborator

Azienda USL Toscana Sud Est (Other)

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic	Combination Product: Rehabilitation combinatory treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 7, 2023

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Patients will receive anodic tEs combined with prismatic lenses for two weeks	Combination Product: Rehabilitation combinatory treatment Combinatory effect of tEs and prismatic lenses
Sham Comparator: Control Patients will receive sham tEs combined with prismatic lenses for two weeks	Combination Product: Rehabilitation combinatory treatment Combinatory effect of tEs and prismatic lenses

Arm

Intervention/Treatment

Experimental: Experimental

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

Combination Product: Rehabilitation combinatory treatment

Combinatory effect of tEs and prismatic lenses

Sham Comparator: Control

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

Combination Product: Rehabilitation combinatory treatment

Combinatory effect of tEs and prismatic lenses

Outcome Measures

Primary Outcome Measures

Neuropsychological outcome [Change from baseline OCS at 2 weeks]
Oxford Cognitive Screening (OCS)
Neuropsychological outcome [Change form baseline the semi structured scale for the functional evaluation of extrapersonale neglect at 2 weeks]
The semi structued scale for the functional evaluation of extrapersonal neglect (0-9); high score means a worse outcome
Neuropsychological outcome [Change form baseline the semi structured scale for the functional evaluation of personale neglect at 2 weeks]
The semi structued scale for the functional evaluation of personal neglect (0-9); high score means worse outcome
Neuropsychological outcome [Change from baseline the Bergegò Scale at 2 weeks.]
Bergegò Scale (0-30); high score means a better outcome
Functional outcome [Change from baseline the Barthel Index at 2 weeks]
Barthel Index (0-100); high score means a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

heamorrhagic stroke
hystory of neurological disease
hystory of psychiatric disease
use of alchool and drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituti Clinici Scientifici Maugeri	Bari	Ba	Italy	70025

Sponsors and Collaborators

Istituti Clinici Scientifici Maugeri SpA
Azienda USL Toscana Sud Est

Investigators

Principal Investigator: Simona Spaccavento, Istituti Clinici Scientifici Maugeri

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Simona Spaccavento, Dr, Istituti Clinici Scientifici Maugeri SpA

ClinicalTrials.gov Identifier:

NCT05842551

Other Study ID Numbers:

1183

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Simona Spaccavento, Dr, Istituti Clinici Scientifici Maugeri SpA

Additional relevant MeSH terms:

Ischemic Stroke

Study Results

No Results Posted as of May 6, 2023