Modulation of Cortical Gamma Synchrony in Stroke

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT05830617
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

Brief Summary

In the last decades, the research in neuroimaging-informed stroke prognosis and treatment has had a little clinical impact, often because of the costs of bringing complex procedures to the bedside. Cerebral stroke remains the leading cause of disability, with 65% of survivors chronically impaired at 6 months. Gamma synchrony (GS) is a fundamental mechanism of cortical function and can be estimated and modulated in a simple, inexpensive, and reliable way. It has provided valuable and cost-effective guidance in several neuropsychiatric conditions. In previous studies, we developed simple yet robust methods for assessing and manipulating GS and proved its relationship with clinical impairment in preliminary data.

The aim of the present project is to predict and improve stroke recovery by leveraging cortical mapping and modulation of GS via transcranial alternating current stimulation (tACS), a safe and inexpensive technique. The project capitalizes on technology readily available to the Italian national health system.

Detailed Description

The project will consist of 3 Work Packages (WPs):

* The aim of WP1 is to map the relationship between GS and clinical outcomes with EEG.

* The aim of WP2 is to translate GS assessment and modulation to bedside.

* The aim of WP3 is to modulate GS to improve rehabilitation outcomes.

Study Timeline

• Study Start: 2021-03-23
• Study First Submitted: 2023-03-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2024-03-23
• Study Completion: 2024-03-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)	immediately after the intervention	Gamma synchrony will be measured via exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). Gamma synchrony will be quantified as power of the EEG gamma band. Gamma synchrony will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony Work Package 1 (WP1)	immediately after the intervention	Gamma synchrony will be measured via exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). Gamma synchrony will be quantified as power of the EEG gamma band. Gamma synchrony will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony Work Package 3 (WP3)	immediately after the intervention	Gamma synchrony will be measured via exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). Gamma synchrony will be quantified as power of the EEG gamma band. Gamma synchrony will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)

Secondary Outcome Measures

Name	Time	Method
Behavioral performance (accuracy). Work Package 1 (WP1)	immediately after the intervention	Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of accuracy (% of correct responses). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (response times). Work Package 1 (WP1)	immediately after the intervention	Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of response times (how fast the participants complete the task). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (response times). Work Package 3 (WP3)	immediately after the intervention	Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of response times (how fast the participants complete the task). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (accuracy). Work Package 3 (WP3)	immediately after the intervention	Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of accuracy (% of correct responses). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)

Trial Locations

Locations (1)

IRCCS San Camillo Hospital; 🇮🇹 Venice, Italy