Modulation of Cortical Gamma Synchrony in Stroke (GAMMASTROKE)

IRCCS San Camillo, Venezia, Italy

Status: Enrolling

Conditions: Stroke

Treatments: Device: real tACS; Device: sham tACS

Study type: Interventional

Funder types: Other

Identifiers

NCT05830617

2020.08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

real tACS

Experimental group

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.

Treatment:

Device: real tACS

sham tACS

Sham Comparator group

Description:

Sham tACS will consist of only 30s of stimulation.

Treatment:

Device: sham tACS