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

NCT04680481 | Completed FDA Device

• 2 other identifiers: STUDY00004009RF1MH124909
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Working Memory

Outcome Measures

Primary Outcomes (2)

• Electrophysiological outcomes

  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

  Changes in working memory performance as measured with the N-back task (quantified with d-prime) during stimulation.

  Immediate effect during stimulation

Study Arms (2)

Stimulation Theta Group

EXPERIMENTAL

Participants will experience traveling wave transcranial alternating current stimulation over the fronto-parietal regions at 4 Hz (theta condition).

Device: Transcranial alternating current stimulation

Stimulation Beta Group

EXPERIMENTAL

Participants will experience traveling wave transcranial alternating current stimulation over the fronto-parietal regions at 23 Hz (beta condition).

Device: Transcranial alternating current stimulation

Interventions

Transcranial alternating current stimulation DEVICE

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.

Stimulation Beta Group; Stimulation Theta Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. diminished capacity to consent;

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alexander Opitz, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 23, 2020
• Study Start: November 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)