StrokeGAMMASTROKENCT05830617
Modulation of Cortical Gamma Synchrony in Stroke
A study testing real tACS in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- real tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2021to 23 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no neurological or psychiatric disorder
- right or left hemisphere damage
- unilateral stroke
- no comorbidities with psychiatric disorders
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo Hospital
Venice
Valeria Camparini, valeria.camparini@hsancamillo.it
About this study
Official title: Assessment and Modulation of Cortical Gamma Synchrony to Predict and Improve Stroke Recovery
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- real tACS, sham tACS
- Keywords
- tACS, gamma synchrony
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real tACSDevice
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 tACSDevice
In WP3, patients will undergo standard intensive rehabilitation plus sham tACS for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: real tACS |
| sham tACS | Sham comparator | Sham tACS will consist of only 30s of stimulation. Receives: Device: sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: immediately after the intervention
Secondary outcomes (8)
Behavioral performance (response times). Work Package 1 (WP1)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of response times (how fast the participants complete the task). Behavioral performance will be measured at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: baseline
Behavioral performance (response times). Work Package 1 (WP1)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of response times (how fast the participants complete the task). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: immediately after the intervention
Behavioral performance (response times). Work Package 3 (WP3)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of response times (how fast the participants complete the task). Behavioral performance will be measured at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: baseline
Behavioral performance (response times). Work Package 3 (WP3)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of response times (how fast the participants complete the task). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: immediately after the intervention
Behavioral performance (accuracy). Work Package 1 (WP1)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of accuracy (% of correct responses). Behavioral performance will be measured at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: baseline
Behavioral performance (accuracy). Work Package 1 (WP1)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of accuracy (% of correct responses). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: immediately after the intervention
Behavioral performance (accuracy). Work Package 3 (WP3)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of accuracy (% of correct responses). Behavioral performance will be measured at the baseline of the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: baseline
Behavioral performance (accuracy). Work Package 3 (WP3)
Participants' cognitive performance at neuropsychological tests will be measured. Behavioral performance will be measured in terms of accuracy (% of correct responses). Behavioral performance will be measured immediately after the intervention (i.e., standard intensive rehabilitation at IRCCS S. Camillo Hospital)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start23 Mar 2021
- Primary completion23 Mar 2024 (estimated)
- Study completion23 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University
- Responsible party
- Sponsor
- Investigators
- Giorgio Arcara, Principal investigator, IRCCS San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830617
- Sponsor's protocol ID
- 2020.08
- Acronym
- GAMMASTROKE
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Modulation of Cortical Gamma Synchrony to Predict and Improve Stroke Recovery
- ClinicalTrials.gov ID
- NCT05830617
- Acronym / sponsor ID
- GAMMASTROKE / 2020.08
- Conditions
- Stroke
- Keywords
- tACS, gamma synchrony
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 23 Mar 2024 (estimated)
- Study completion
- 23 Mar 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tACS | Experimental | Device: real tACSReal 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. |
| sham tACS | Sham comparator | Device: sham tACSSham tACS will consist of only 30s of stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no neurological or psychiatric disorder
- right or left hemisphere damage
- unilateral stroke
- no comorbidities with psychiatric disorders
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real tACSThe effect of transcranial alternating current stimulation (tACS) will be investigated in WP3. Patients will undergo standard intensive rehabilitation plus gamma tACS for two weeks. | Device | real tACS |
| sham tACSIn WP3, patients will undergo standard intensive rehabilitation plus sham tACS for two weeks. | Device | sham tACS |
Primary outcome
Gamma synchrony Work Package 1 (WP1)
Time frame: baseline
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)
Gamma synchrony Work Package 1 (WP1)
Time frame: immediately after the intervention
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)
Gamma synchrony Work Package 3 (WP3)
Time frame: baseline
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)
Gamma synchrony Work Package 3 (WP3)
Time frame: immediately after the intervention
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)
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
Time frame: baseline
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)
Gamma synchrony (reduced number of EEG sensors). Work Package 2 (WP2)
Time frame: immediately after the intervention
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)
8 secondary outcomes
Behavioral performance (response times). Work Package 1 (WP1)
Time frame: baseline
Behavioral performance (response times). Work Package 1 (WP1)
Time frame: immediately after the intervention
Behavioral performance (response times). Work Package 3 (WP3)
Time frame: baseline
Behavioral performance (response times). Work Package 3 (WP3)
Time frame: immediately after the intervention
Behavioral performance (accuracy). Work Package 1 (WP1)
Time frame: baseline
Behavioral performance (accuracy). Work Package 1 (WP1)
Time frame: immediately after the intervention
Behavioral performance (accuracy). Work Package 3 (WP3)
Time frame: baseline
Behavioral performance (accuracy). Work Package 3 (WP3)
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Arcara principal investigator
IRCCS San Camillo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tACS in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Arcara (0412207594, giorgio.arcara@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma synchrony Work Package 1 (WP1) (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.