Modulation of Cortical Gamma Synchrony in Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2024-03-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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real tACS

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.

Group Type EXPERIMENTAL

real tACS

Intervention Type 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.

sham tACS

Sham tACS will consist of only 30s of stimulation.

Group Type SHAM_COMPARATOR

sham tACS

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

sham tACS

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- no neurological or psychiatric disorder

* right or left hemisphere damage
* unilateral stroke
* no comorbidities with psychiatric disorders

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes