Modulation of Cortical Gamma Synchrony in Stroke

Stroke Clinical Trial

— GAMMASTROKE  

Official title:

Assessment and Modulation of Cortical Gamma Synchrony to Predict and Improve Stroke Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830617
• Other study ID #: 2020.08
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: March 23, 2024

Study information

• Verified date: April 2023
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Giorgio Arcara
• Phone: 0412207594
• Email: giorgio.arcara[@]hsancamillo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 23, 2024
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• real tACS
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.
• sham tACS
In WP3, patients will undergo standard intensive rehabilitation plus sham tACS for two weeks.

Locations

Country	Name	City	State
Italy	IRCCS San Camillo Hospital	Venice

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy	Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline
Primary	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)	immediately after the intervention
Primary	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)	baseline
Primary	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)	immediately after the intervention
Primary	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)	baseline
Primary	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)	immediately after the intervention
Secondary	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)	baseline
Secondary	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)	immediately after the intervention
Secondary	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)	baseline
Secondary	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)	immediately after the intervention
Secondary	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)	baseline
Secondary	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)	immediately after the intervention
Secondary	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)	baseline
Secondary	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)	immediately after the intervention