Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks

February 16, 2024 updated by: University of Minnesota

Traveling Wave Transcranial Alternating Current Stimulation for the Control of Large-Scale Brain Networks

This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

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: Ivan Alekseichuk, PhD
  • Phone Number: 612-624-1118
  • Email: ialeksei@umn.edu

Study Contact Backup

  • Name: Alexander Opitz, PhD
  • Phone Number: 612-624-1094
  • Email: aopitz@umn.edu

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Alexander Opitz, PhD
        • Sub-Investigator:
          • Ivan Alekseichuk, PhD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. the patient can consent for themselves;
  2. the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation;
  3. age 18+ years old;

Exclusion Criteria:

1. diminished capacity to consent;

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation Theta Group
Participants will experience traveling wave transcranial alternating current stimulation over the fronto-parietal regions at 4 Hz (theta condition).
Device: Transcranial alternating current stimulation
Traveling wave transcranial alternating current stimulation will be applied at 4 Hz and 23 Hz over frontal and parietal brain areas in a randomized counterbalanced order.
Experimental: Stimulation Beta Group
Participants will experience traveling wave transcranial alternating current stimulation over the fronto-parietal regions at 23 Hz (beta condition).
Device: Transcranial alternating current stimulation
Traveling wave transcranial alternating current stimulation will be applied at 4 Hz and 23 Hz over frontal and parietal brain areas in a randomized counterbalanced order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrophysiological outcomes
Time Frame: Immediate effect during stimulation
Changes in spectral power and coherence of the local field potentials during transcranial electric stimulation relative to no stimulation periods.
Immediate effect during stimulation
Working memory outcomes
Time Frame: Immediate effect during stimulation
Changes in working memory performance as measured with the N-back task (quantified with d-prime) during stimulation.
Immediate effect during stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Alexander Opitz, 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)

November 1, 2020

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00004009
  • RF1MH124909 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared following the IRB guidelines and Data Sharing Policy for the National Institute of Mental Health (NOT-MH-19-033).

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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