Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04680481
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : January 28, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Working Memory Device: Transcranial alternating current stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Traveling Wave Transcranial Alternating Current Stimulation for the Control of Large-Scale Brain Networks
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680481


Contacts
Layout table for location contacts
Contact: Alexander Opitz, PhD 612-624-1094 aopitz@umn.edu
Contact: Ivan Alekseichuk, PhD 612-624-1118 ialeksei@umn.edu

Locations
Layout table for location information
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ivan Alekseichuk, PhD    612-626-1118    ialeksei@umn.edu   
Principal Investigator: Alexander Opitz, PhD         
Sub-Investigator: Ivan Alekseichuk, PhD         
Sponsors and Collaborators
University of Minnesota
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Alexander Opitz, PhD University of Minnesota
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04680481    
Other Study ID Numbers: STUDY00004009
RF1MH124909 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

Layout table for additional information
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