Modulation of Cortical Gamma Synchrony in Stroke

Last updated: April 13, 2023
Sponsor: IRCCS San Camillo, Venezia, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05830617
2020.08
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 220
Study Start date:
March 23, 2021
Estimated Completion Date:
March 23, 2024

Study 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.

Connect with a study center

  • IRCCS San Camillo Hospital

    Venice,
    Italy

    Active - Recruiting

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