NCT05842551

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Dec 2026

Study Start

First participant enrolled

March 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3.4 years

First QC Date

April 24, 2023

Last Update Submit

September 1, 2025

Conditions

Stroke, Ischemic

Keywords

strokeneglecttDCSprismatic lenses

Outcome Measures

Primary Outcomes (5)

  • 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)

    Change from baseline OCS at 2 weeks

  • Neuropsychological outcome

    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

    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

  • Neuropsychological outcome

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

    Change from baseline the Bergegò Scale at 2 weeks.

  • Functional outcome

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

    Change from baseline the Barthel Index at 2 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

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

Combination Product: Prismatic adaptation and electric stimulation

Control

SHAM COMPARATOR

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

Combination Product: Prismatic adaptation and electric stimulation

Interventions

Prismatic adaptation and electric stimulationCOMBINATION_PRODUCT

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

ControlExperimental

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • heamorrhagic stroke
  • history of neurological disease
  • history of psychiatric disease
  • use of alchool and drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Bari, Ba, 70025, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Simona Spaccavento

    Istituti Clinici Scientifici Maugeri

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Spaccavento

CONTACT

+393332783524simona.spaccavento@icsmaugeri.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

March 7, 2023

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

IT(1)