Prismatic Lenses and tDCS in Neglect

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842551
• Other study ID #: 1183
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Simona Spaccavento
• Phone: +393332783524
• Email: simona.spaccavento[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

Intervention

Combination Product:
• Prismatic 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

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Bari	Ba

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Azienda USL Toscana Sud Est

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Neuropsychological outcome	Bergegò Scale (0-30); high score means a better outcome	Change from baseline the Bergegò Scale at 2 weeks.
Primary	Functional outcome	Barthel Index (0-100); high score means a better outcome	Change from baseline the Barthel Index at 2 weeks