Modulation of Cortical Gamma Synchrony in Stroke

NCT05830617 | Unknown

• 1 other identifier: 2020.08
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

tACS; gamma synchrony

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Behavioral performance (response times). Work Package 1 (WP1)

  baseline

• Behavioral performance (response times). Work Package 1 (WP1)

  immediately after the intervention

• Behavioral performance (response times). Work Package 3 (WP3)

  baseline

• Behavioral performance (response times). Work Package 3 (WP3)

  immediately after the intervention

• Behavioral performance (accuracy). Work Package 1 (WP1)

  baseline

Study Arms (2)

real tACS

EXPERIMENTAL

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.

Device: real tACS

sham tACS

SHAM COMPARATOR

Sham tACS will consist of only 30s of stimulation.

Device: sham tACS

Interventions

real tACS DEVICE

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.

real tACS

sham tACS DEVICE

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

sham tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- no neurological or psychiatric disorder
• right or left hemisphere damage
• unilateral stroke
• no comorbidities with psychiatric disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Campus Bio-Medico University: collaborator

Study Sites (1)

IRCCS San Camillo Hospital

Venice, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giorgio Arcara

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Arcara

CONTACT

0412207594; giorgio.arcara@hsancamillo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 26, 2023
• Study Start: March 23, 2021
• Primary Completion: March 23, 2024
• Study Completion: March 23, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)