Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I

NCT ID: NCT03672747

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2023-05-31

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

Detailed Description

An emerging neurological tool, called transcranial Direct Current Stimulation (tDCS), has recently been shown to safely and effectively enhance cognition in healthy individuals, as well as reduce key symptomatology in disorders such as stroke and depression, with only negligible side effects. tDCS delivers low-amplitude current to the scalp using small electrodes and part of this current passes through the skull and modulates neural activity in the underlying brain region. How this tiny amount of electric current acts to improve cognitive function and reduce symptoms (e.g., motor impairments in stroke patients with a lesion in motor brain areas) is currently unknown, although many investigators across the world are now working on this problem. Magnetoencephalography (MEG) offers a unique view of neural function, as it can delineate changes in active brain regions with excellent temporal resolution (< 1 ms) and high spatial accuracy (2-3 mm). MEG non-invasively measures the magnetic fields that emanate from active neocortical cells. The potential of the MEG technique to precisely monitor the neural effects of tDCS shows extreme promise, but to date the method has been rarely utilized in this area.

Under this protocol, Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I, approximately 124 participants will provide written informed consent, undergo cognitive and behavioral testing and a structural MRI during a single visit, and then return several weeks later (2-4 weeks) to complete a short tDCS session followed by a MEG recording (i.e., after tDCS). Most participants will return for two more visits, each separated by 2-4 weeks, that include a tDCS session followed by a MEG recording (i.e., 4 total visits). The three tDCS-MEG visits will be identical except that the nature of the stimulation (e.g., location, amplitude, direction/polarity) will be different.

Conditions

Brain Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Anodal Brain Stimulation

Participants will receive anodal stimulation using high-definition tDCS

Group Type: ACTIVE_COMPARATOR

transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

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

Cathodal Brain Stimulation

Participants will receive cathodal stimulation using high-definition tDCS

Group Type: ACTIVE_COMPARATOR

transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

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

Sham Brain Stimulation (Placebo)

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

Group Type: SHAM_COMPARATOR

transcranial direct-current stimulation (tDCS)

Intervention Type: DEVICE

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

Interventions

transcranial direct-current stimulation (tDCS)

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

Intervention Type: DEVICE

Other Intervention Names

Transcranial electrical stimulation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony W Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RF1MH117032

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0580-18-FB

Identifier Type: -

Identifier Source: org_study_id