NCT05327829

Brief Summary

This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
21mo left

Started Jan 2025

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Jan 2028

First Submitted

Initial submission to the registry

February 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

February 28, 2022

Last Update Submit

March 12, 2025

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI

    Using non-invasive transcranial alternating current stimulation, it will be determined if this study is feasible for improving cognitive recovery after mild to moderate brain injury. To determine the sum total of completion rate of study procedures.

    3 years

Study Arms (2)

Sham

SHAM COMPARATOR

No stimulation

Behavioral: COGED

Stimulation

ACTIVE COMPARATOR

Stimulation

Combination Product: External non-invasive stimulationBehavioral: COGED

Interventions

External non-invasive stimulationCOMBINATION_PRODUCT

The participants are randomized into the block design of sham or tACS during the first three appointments or the last three appointments. Eye tracking will be used to test the predominant focus of decisions during the gaze phase on costs or difficulty levels during the COGED. The study is investigating the use of neuromodulation after TBI for improved cognitive function.

Stimulation
COGEDBEHAVIORAL

The COGED task consists of the classic N-back task of working memory-based decision making, followed by a valuation phase. The N-back phase of the task allows calculation of cognitive performance of a working memory task. During valuation, participants receive titrating offers of differing amounts of money to perform different difficulty levels of the N-back. The result is an effort discounting curve used to measure the individual effort cost. Effort discounting curves show the perceived cognitive effort required to complete each level of the task relative to another (typically the 1-back).

ShamStimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years and older
  • Diagnosis of a mild to moderate TBI (GCS \> 8 on admission)
  • Able to perform a computerized assessment
  • Willing to attend all scheduled appointments
  • Able to undergo the informed consent process
  • Healthy participants:
  • Adults 18 years and older
  • Able to perform a computerized assessment
  • Willing to attend all scheduled appointments
  • Able to undergo the informed consent process

You may not qualify if:

  • Open wound on scalp
  • Severe TBI diagnosis or GCS of less than 8 on admission
  • Non-English speaking
  • Incarcerated
  • Implanted defibrillator or pacemaker
  • Visual impairment that hinders ability to complete computerized assessments
  • Less than 18 years of age
  • Open wound on scalp
  • TBI diagnosis
  • Non-English speaking
  • Incarcerated
  • Implanted defibrillator or pacemaker
  • Visual impairment that hinders ability to complete computerized assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • David Darrow, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Darrow, MD

CONTACT

612-873-7481Darro015@umn.edu

David Darrow, MD

CONTACT

darro015@umn.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded to stimulation versus no stimulation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Block design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

April 14, 2022

Study Start

January 15, 2025

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2028

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)