Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I

NCT03672747 | Completed Results FDA Device

• 2 other identifiers: 0580-18-FBRF1MH117032
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether transcranial direct current stimulation (tDCS) can be used alter the amplitude of spontaneous neural activity, and thereby modulate cognitive function in healthy adults

Conditions

Brain Function

Outcome Measures

Primary Outcomes (2)

• Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing

  Do participants perform better in terms of accuracy following tDCS on behavioral measures of perceptual processing.

  During the 90 minutes following stimulation

• Behavioral Performance (Reaction Time) on Cognitive Tests of Perceptual Processing

  Do participants perform better in terms of reaction time following tDCS on behavioral measures of perceptual processing.

  During the 90 minutes following stimulation

Secondary Outcomes (4)

• The Power of Spontaneous Alpha Activity as Quantified by MEG Imaging

  During the 90 minutes following stimulation

• The Power of Oscillatory Alpha Activity as Quantified by MEG Imaging

  During the 90 minutes following stimulation

• The Power of Spontaneous Gamma Activity as Quantified by MEG Imaging

  During the 90 minutes following stimulation

• The Power of Oscillatory Gamma Activity as Quantified by MEG Imaging

  During the 90 minutes following stimulation

Study Arms (3)

Anodal Brain Stimulation

ACTIVE COMPARATOR

Participants will receive anodal stimulation using high-definition tDCS

Device: transcranial direct-current stimulation (tDCS)

Cathodal Brain Stimulation

ACTIVE COMPARATOR

Participants will receive cathodal stimulation using high-definition tDCS

Device: transcranial direct-current stimulation (tDCS)

Sham Brain Stimulation (Placebo)

SHAM COMPARATOR

Participants will receive sham stimulation (placebo) using high-definition tDCS

Device: transcranial direct-current stimulation (tDCS)

Interventions

transcranial direct-current stimulation (tDCS) DEVICE

20 minutes duration using high-definition system with center-surround configuration

Also known as: Transcranial electrical stimulation

Anodal Brain Stimulation; Cathodal Brain Stimulation; Sham Brain Stimulation (Placebo)

Eligibility Criteria

• Age: 19 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained from the participant.
• Age: 19-35 years of age at enrollment or 55-72 years of age at enrollment.
• Gender: males and females included.
• Right-handed based on the Edinburgh Handedness Inventory
• Cognitive functioning: Intelligent Quotient (IQ) of 85 - 115 on the Wechsler Adult Intelligence Scale-Revised
• Ability to complete the questionnaires in English, as not all the neuropsychological tests and questionnaires have been validated in other languages.

You may not qualify if:

• Current use of the following medications: psychotropic medications or other medications with significant CNS effects (e.g., antipsychotics, psychostimulants, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, and sedating antihistamines), or other excluded medication.
• Current psychiatric diagnosis based on the Mini-International Neuropsychiatric Interview (MINI) and/or the adult attention-deficit/hyperactivity disorder (ADHD) diagnostic interview.
• Current substance abuse or substance dependence at any time.
• The presence of a known neurological disorder or any major medical illness or injury impacting neurological/psychiatric function (e.g., diabetes, epilepsy, cerebral palsy, traumatic brain injury, significant environmental/toxic injury, neurodegenerative disorder, past meningitis/encephalitis).
• General medical conditions: any major medical conditions that would interfere with involvement in the study or may affect central nervous system (CNS) function as judged by the investigative team.
• History of clinically-significant head trauma.
• Pregnancy
• Any other condition that, in the opinion of the investigator, is a contraindication to participation
• The presence of any ferrous metal implant, including orthodontics (e.g., braces), which may interfere with the MEG data acquisition and/or be a MRI safety concern.
• Inability to correct visual acuity to 20/20 with corrective lenses (we can correct from +5 to -6 diopters in .5 diopter steps, separately for each eye, with non-magnetic corrective lenses in the laboratory).

Sponsors & Collaborators

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

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, 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

Limitations and Caveats

Focus on single stimulation amplitude and duration.

Results Point of Contact

• Title: Tony Wilson
• Organization: Boys Town National Research Hospital

tony.w.wilson@gmail.com

531-355-8909

Study Officials

• Tony W Wilson, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Full crossover; all participants complete all conditions

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: September 14, 2018
• Study Start: February 20, 2019
• Primary Completion: October 14, 2022
• Study Completion: May 31, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be fully updated by the end of the study and will remain publicly available indefinitely.
• Access Criteria: Approval/Account from the NIMH

Locations

US (1)