- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05923606
Modulation of Brain Oscillations Underlying Working Memory
March 11, 2024 updated by: Hamdi Eryilmaz, PhD, Massachusetts General Hospital
State-dependent Modulation of Interactions of Theta and Gamma Rhythms in Working Memory
This study will use novel transcranial alternating current stimulation (tACS) protocols and electroencephalography (EEG) to modulate and measure brain oscillations that underlie working memory.
tACS is a noninvasive method used to modulate the timing and patterns of brain rhythms via weak electric currents passed through electrodes on the scalp.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In this study, healthy adult individuals will perform a spatial working memory task as investigators record scalp EEG before and immediately after undergoing transcranial alternating current stimulation (tACS).
Each participant will complete four tACS sessions in randomized order: 1) theta-nested gamma tACS applied during active task periods, 2) theta-nested gamma tACS applied during passive (rest) periods, 3) gamma stimulation applied in phase with ongoing theta oscillations, and 4) placebo tACS.
The different stimulation protocols will take place on different days.
Therefore, participants will be expected to attend 4 in-person study visits at the Martinos Center for Biomedical Imaging in Charlestown, Massachusetts.
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandra O'Neill, B.S.
- Phone Number: (617) 726-8753
- Email: agoneill@mgh.harvard.edu
Study Contact Backup
- Name: Hamdi Eryilmaz, Ph.D.
- Phone Number: (617) 643-7462
- Email: hamdi.eryilmaz@mgh.harvard.edu
Study Locations
-
-
Massachusetts
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Charlestown, Massachusetts, United States, 02129
- Martinos Center for Biomedical Imaging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able to provide informed consent
- Fluent in English.
Exclusion Criteria:
- History of a neurological/psychiatric disorder
- Current use of psychotropic medications
- Current use of substances and drugs that were shown to affect tES (transcranial electrical stimulation) efficacy (dopamine altering drugs, nicotine, NMDA (N-methyl-D-aspartate) antagonists/agonists, sodium/calcium channel blockers, norepinephrine reuptake inhibitors, GABAergic modulators and selective serotonin reuptake inhibitors)
- Contraindications for tACS (e.g., history of seizures, metallic implants in the head or neck, implanted brain stimulators, vagus nerve stimulators, pacemakers, pregnancy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Theta-nested gamma tACS applied during passive task epochs
Participants will receive single-session administration of tACS during performance of a working memory task.
tACS will be applied during fixation periods between consecutive task trials.
EEG will be acquired before and immediately after the intervention.
|
Active tACS will be administered over the left dorsolateral prefrontal cortex for approximately 25 minutes.
|
Experimental: Theta-nested gamma tACS applied during memory delays
Participants will receive single-session administration of tACS during performance of a working memory task.
tACS will be applied during memory delays.
EEG will be acquired before and immediately after the intervention.
|
Active tACS will be administered over the left dorsolateral prefrontal cortex for approximately 25 minutes.
|
Experimental: Gamma tACS applied during memory delays
Participants will receive single-session administration of tACS during performance of a working memory task.
tACS will be applied during memory delays.
The stimulation will be phase locked to the peaks of ongoing theta rhythms of the participant.
EEG will be acquired before and immediately after the intervention.
|
Active tACS will be administered over the left dorsolateral prefrontal cortex for approximately 25 minutes.
|
Placebo Comparator: Placebo tACS applied during task performance
Participants will receive single-session administration of placebo tACS during performance of a working memory task.
EEG will be acquired before and immediately after the intervention.
|
Placebo tACS will be administered over the left dorsolateral prefrontal cortex for approximately 25 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working memory accuracy
Time Frame: 2 hours
|
Accuracy of working memory retrieval during a Delayed Match-to-Sample task will be assessed before and during tACS interventions
|
2 hours
|
Working memory accuracy under interference
Time Frame: 2 hours
|
Accuracy of working memory retrieval during interference conditions of a Delayed Match-to-Sample task will be assessed before and during tACS interventions.
|
2 hours
|
Theta-gamma cross-frequency coupling
Time Frame: 2 hours
|
Cross-frequency coupling between theta band phase and gamma band amplitude will be calculated using the EEG data collected while subjects perform the Delayed Match-to-Sample task before and after tACS interventions.
|
2 hours
|
Fronto-parietal theta phase synchronization
Time Frame: 2 hours
|
Phase synchronization in the theta band between frontal and parietal brain regions will be calculated using the EEG data collected while subjects perform the Delayed Match-to-Sample task before and after the tACS interventions.
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hamdi Eryilmaz, Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
June 20, 2023
First Submitted That Met QC Criteria
June 27, 2023
First Posted (Actual)
June 28, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2023P001479
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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