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Modulation of Cortical Gamma Synchrony in Stroke (GAMMASTROKE)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
real tACS
sham tACS
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tACS, gamma synchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The participants in this study will be 140 stroke patients rehabilitated at IRCCS San Camillo hospital. 80 will participate in the WP1 and the WP2, while 60 will participate in the WP3 study. In WP1, data will also be collected on 80 healthy volunteer participants, approximately the same age as the patients. Inclusion Criteria (healthy participants) - no neurological or psychiatric disorder Inclusion Criteria (patients) right or left hemisphere damage unilateral stroke no comorbidities with psychiatric disorders Exclusion Criteria (general): Diagnosis of epilepsy or family history up to the second degree with it Episodes of febrile convulsions or recurrent fainting Head trauma Presence of surgical clips or metal implants in the head Diagnosis of heart disease Presence of a cardiac pacemaker or artificial heart valve Presence of hearing aids/prostheses Hearing problems or tinnitus Vision problems not corrected with lenses (such as color blindness) Taking tricyclic antidepressant medications Taking neuroleptic medications Diagnosis of headache or migraine

Sites / Locations

  • IRCCS San Camillo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tACS

sham tACS

Arm Description

Real tACS will be delivered by applying two conductive electrodes over the left and right central areas, for 30 minutes/day (Monday-to-Friday), for two weeks, with the following parameters: sinewaves at 40Hz, peak-to-peak amplitude=1mA, 3s ramping-up and ramping-down. Intensity will be lowered if perceived as uncomfortable.

Sham tACS will consist of only 30s of stimulation.

Outcomes

Primary Outcome Measures

Gamma synchrony Work Package 1 (WP1)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony Work Package 1 (WP1)
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)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony Work Package 3 (WP3)
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 (reduced number of EEG sensors). Work Package 2 (WP2)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
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

Behavioral performance (response times). Work Package 1 (WP1)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (response times). Work Package 1 (WP1)
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)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (response times). Work Package 3 (WP3)
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 1 (WP1)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (accuracy). Work Package 1 (WP1)
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 (accuracy). Work Package 3 (WP3)
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Behavioral performance (accuracy). Work Package 3 (WP3)
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)

Full Information

First Posted
March 16, 2023
Last Updated
April 13, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT05830617
Brief Title
Modulation of Cortical Gamma Synchrony in Stroke
Acronym
GAMMASTROKE
Official Title
Assessment and Modulation of Cortical Gamma Synchrony to Predict and Improve Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
March 23, 2024 (Anticipated)
Study Completion Date
March 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Campus Bio-Medico University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
tACS, gamma synchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real tACS
Arm Type
Experimental
Arm Description
Real tACS will be delivered by applying two conductive electrodes over the left and right central areas, for 30 minutes/day (Monday-to-Friday), for two weeks, with the following parameters: sinewaves at 40Hz, peak-to-peak amplitude=1mA, 3s ramping-up and ramping-down. Intensity will be lowered if perceived as uncomfortable.
Arm Title
sham tACS
Arm Type
Sham Comparator
Arm Description
Sham tACS will consist of only 30s of stimulation.
Intervention Type
Device
Intervention Name(s)
real tACS
Intervention Description
The effect of transcranial alternating current stimulation (tACS) will be investigated in WP3. Patients will undergo standard intensive rehabilitation plus gamma tACS for two weeks.
Intervention Type
Device
Intervention Name(s)
sham tACS
Intervention Description
In WP3, patients will undergo standard intensive rehabilitation plus sham tACS for two weeks.
Primary Outcome Measure Information:
Title
Gamma synchrony Work Package 1 (WP1)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Gamma synchrony Work Package 1 (WP1)
Description
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)
Time Frame
immediately after the intervention
Title
Gamma synchrony Work Package 3 (WP3)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Gamma synchrony Work Package 3 (WP3)
Description
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)
Time Frame
immediately after the intervention
Title
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
Description
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)
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Behavioral performance (response times). Work Package 1 (WP1)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Behavioral performance (response times). Work Package 1 (WP1)
Description
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)
Time Frame
immediately after the intervention
Title
Behavioral performance (response times). Work Package 3 (WP3)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Behavioral performance (response times). Work Package 3 (WP3)
Description
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)
Time Frame
immediately after the intervention
Title
Behavioral performance (accuracy). Work Package 1 (WP1)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Behavioral performance (accuracy). Work Package 1 (WP1)
Description
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)
Time Frame
immediately after the intervention
Title
Behavioral performance (accuracy). Work Package 3 (WP3)
Description
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 at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Time Frame
baseline
Title
Behavioral performance (accuracy). Work Package 3 (WP3)
Description
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)
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The participants in this study will be 140 stroke patients rehabilitated at IRCCS San Camillo hospital. 80 will participate in the WP1 and the WP2, while 60 will participate in the WP3 study. In WP1, data will also be collected on 80 healthy volunteer participants, approximately the same age as the patients. Inclusion Criteria (healthy participants) - no neurological or psychiatric disorder Inclusion Criteria (patients) right or left hemisphere damage unilateral stroke no comorbidities with psychiatric disorders Exclusion Criteria (general): Diagnosis of epilepsy or family history up to the second degree with it Episodes of febrile convulsions or recurrent fainting Head trauma Presence of surgical clips or metal implants in the head Diagnosis of heart disease Presence of a cardiac pacemaker or artificial heart valve Presence of hearing aids/prostheses Hearing problems or tinnitus Vision problems not corrected with lenses (such as color blindness) Taking tricyclic antidepressant medications Taking neuroleptic medications Diagnosis of headache or migraine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgio Arcara
Phone
0412207594
Email
giorgio.arcara@hsancamillo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Arcara
Organizational Affiliation
IRCCS San Camillo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Camillo Hospital
City
Venice
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Camparini
Email
valeria.camparini@hsancamillo.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Modulation of Cortical Gamma Synchrony in Stroke

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