Clinical trial NCT05830617: Modulation of Cortical Gamma Synchrony in Stroke
Official title: Assessment and Modulation of Cortical Gamma Synchrony to Predict and Improve Stroke Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: tACS
gamma synchrony
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico University
First posted: 2023-04-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gamma synchrony Work Package 1 (WP1)
timeFrame: baseline
measure: Gamma synchrony Work Package 1 (WP1)
timeFrame: immediately after the intervention
measure: Gamma synchrony Work Package 3 (WP3)
timeFrame: baseline
measure: Gamma synchrony Work Package 3 (WP3)
timeFrame: immediately after the intervention
measure: Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
timeFrame: baseline
measure: Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Behavioral performance (response times). Work Package 1 (WP1)
timeFrame: baseline
measure: Behavioral performance (response times). Work Package 1 (WP1)
timeFrame: immediately after the intervention
measure: Behavioral performance (response times). Work Package 3 (WP3)
timeFrame: baseline
measure: Behavioral performance (response times). Work Package 3 (WP3)
timeFrame: immediately after the intervention
measure: Behavioral performance (accuracy). Work Package 1 (WP1)
timeFrame: baseline
measure: Behavioral performance (accuracy). Work Package 1 (WP1)
timeFrame: immediately after the intervention
measure: Behavioral performance (accuracy). Work Package 3 (WP3)
timeFrame: baseline
measure: Behavioral performance (accuracy). Work Package 3 (WP3)
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Giorgio Arcara
role: PRINCIPAL_INVESTIGATOR
References: