- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399381
Traveling-wave Transcranial Electric Stimulation (TravelingTES)
February 3, 2025 updated by: University of Minnesota
Precision Transcranial Electric Stimulation for the Therapy of Cognitive Impairment
This study will assess the impact of traveling wave transcranial alternating current stimulation (tACS) on working memory performance in adults.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Transcranial alternating current stimulation (tACS) can non-invasively alter neuroelectric activity in the brain by applying weak time-varying electric currents via the scalp.
Complex patterns of electric brain activity can take the form of traveling waves - spatially coherent brain rhythms that gradually propagate through the neocortex.
Traveling waves are crucial for the temporal coordination of informational flow in the brain.
Using the novel traveling-wave transcranial alternating current stimulation (tACS) approach, the investigators will explore the effects of frontal-to-parietal and parietal-to-frontal traveling waves on working memory performance and brain electrophysiology in adults.
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18 and 45 years old.
- Confident level of English language.
Exclusion Criteria:
- History or evidence of chronic neurological or mental disorder.
- Metal or electric implant in the head, neck, or chest area.
- History of head injuries with loss of consciousness.
- Any acute or chronic medical condition that requires ongoing pharmacological treatment.
- Pregnancy or breast-feeding.
- Alcohol or drug addiction.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Frontoparietal Slow Theta Stimulation
Participants will receive multi-electrode transcranial alternating current stimulation over the prefrontal and parietal brain regions that induces frontal-to-parietal traveling wave at the frequency of 4 Hz with the intensity of up to 2 mA and duration up to 20 min.
|
Non-invasive, multi-electrode transcranial alternating current stimulation (tACS) over frontal and parietal brain areas.
|
|
Experimental: Frontoparietal Fast Theta Stimulation
Participants will receive multi-electrode transcranial alternating current stimulation over the prefrontal and parietal brain regions that induces frontal-to-parietal traveling wave at the frequency of 7 Hz with the intensity of up to 2 mA and duration up to 20 min.
|
Non-invasive, multi-electrode transcranial alternating current stimulation (tACS) over frontal and parietal brain areas.
|
|
Experimental: Parietofrontal Slow Theta Stimulation
Participants will receive multi-electrode transcranial alternating current stimulation over the prefrontal and parietal brain regions that induces parietal-to-frontal traveling wave at the frequency of 4 Hz with the intensity of up to 2 mA and duration up to 20 min.
|
Non-invasive, multi-electrode transcranial alternating current stimulation (tACS) over frontal and parietal brain areas.
|
|
Experimental: Parietofrontal Fast Theta Stimulation
Participants will receive multi-electrode transcranial alternating current stimulation over the prefrontal and parietal brain regions that induces parietal-to-frontal traveling wave at the frequency of 7 Hz with the intensity of up to 2 mA and duration up to 20 min.
|
Non-invasive, multi-electrode transcranial alternating current stimulation (tACS) over frontal and parietal brain areas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in working memory performance
Time Frame: Immediate effect during stimulation
|
Changes in working memory performance (% of correct responses) as measured with the standardized N-back working memory task during active stimulation relative to pre-stimulation performance.
|
Immediate effect during stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in reaction time
Time Frame: Immediate effect during stimulation
|
Changes in reaction time (milliseconds) as measured using the standardized N-back working memory task during active stimulation relative to pre-stimulation performance.
|
Immediate effect during stimulation
|
|
Changes in electroencephalographic (EEG) connectivity
Time Frame: Five minutes post-stimulation
|
Changes in electroencephalographic (EEG) connectivity in theta band (in normalized units) after transcranial electric stimulation relative to pre-stimulation periods.
|
Five minutes post-stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ivan Alekseichuk, PhD, University of Minnesota
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 (Actual)
September 5, 2022
Primary Completion (Actual)
February 1, 2025
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
April 6, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00002876
- 30064 (Other Grant/Funding Number: Brain & Behavior Research Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Full or partial access to the preprocessed data will be provided upon the request to the faculty / research staff of recognized research, medical, and educational institutions for educational and scientific purposes.
The request should be sent via an institutional email and will be stored with the study materials.
The request should include a short description of the scientific or educational aims.
IPD Sharing Time Frame
Data will be shared only upon request after the study has ended (within 6 months).
IPD Sharing Access Criteria
To receive access, the study investigators need to be contacted via an institutional e-mail including a short description of the scientific or educational aims.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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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