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Brain FunctionNCT03672747

Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I

A study testing transcranial direct-current stimulation (tDCS) in people with Brain Function, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 72 yearsHealthy volunteers can take part
Conditions the study is for
Brain Function
What is being tested?
transcranial direct-current stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
1 siteUnited States
Study dates
20 Feb 2019to 31 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 72 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: The Impact of Spontaneous Cortical Activity on Neural Oscillations and Behavioral Performance: Evidence From High-definition tDCS and MEG

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

Read the 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
Being tested
transcranial direct-current stimulation (tDCS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct-current stimulation (tDCS)Device

    Also called Transcranial electrical stimulation

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

Study groups in NCT03672747
Study groupRoleWhat they receive
Anodal Brain StimulationActive comparatorParticipants will receive anodal stimulation using high-definition tDCS
Receives: Device: transcranial direct-current stimulation (tDCS)
Cathodal Brain StimulationActive comparatorParticipants will receive cathodal stimulation using high-definition tDCS
Receives: Device: transcranial direct-current stimulation (tDCS)
Sham Brain Stimulation (Placebo)Sham comparatorParticipants will receive sham stimulation (placebo) using high-definition tDCS
Receives: Device: transcranial direct-current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the 90 minutes following stimulation

  2. 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.

    Measured: During the 90 minutes following stimulation

Secondary outcomes (4)

  1. The Power of Spontaneous Alpha Activity as Quantified by MEG Imaging

    Does spontaneous alpha (9-13 Hz) power, as measured by MEG, get stronger following tDCS. Spontaneous activity refers to the level of background neural activity and is typically divided into frequency bands (e.g., alpha, gamma) that reflect the number of cycles per second. The outcome measure unit is nano-amperes square (nA^2) since source-resolved MEG measures reflect electric current strength and not voltage units as in electroencephalography (EEG). The square is necessary since we examined power, which is the square of amplitude in the frequency domain. The unit is also commonly expressed as nAm^2 since the strength of the electric current is over a defined length.

    Measured: During the 90 minutes following stimulation

  2. The Power of Oscillatory Alpha Activity as Quantified by MEG Imaging

    Does oscillatory alpha neural activity, as measured by MEG, get stronger following tDCS. Oscillatory activity refers band-limited increases or decreases in the power of neural activity, relative to baseline, in response to a stimulus.

    Measured: During the 90 minutes following stimulation

  3. The Power of Spontaneous Gamma Activity as Quantified by MEG Imaging

    Does spontaneous gamma (45-80 Hz) power, as measured by MEG, get stronger following tDCS. Spontaneous activity refers to the level of background neural activity and is typically divided into frequency bands (e.g., alpha, gamma) that reflect the number of cycles per second. The outcome measure unit is nano-amperes square (nA^2) since source-resolved MEG measures reflect electric current strength and not voltage units as in electroencephalography (EEG). The square is necessary since we examined power, which is the square of amplitude in the frequency domain. The unit is also commonly expressed as nAm^2 since the strength of the electric current is over a defined length.

    Measured: During the 90 minutes following stimulation

  4. The Power of Oscillatory Gamma Activity as Quantified by MEG Imaging

    Does oscillatory gamma neural activity, as measured by MEG, get stronger following tDCS. Oscillatory activity refers band-limited increases or decreases in the power of neural activity, relative to baseline, in response to a stimulus.

    Measured: During the 90 minutes following stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start20 Feb 2019
  3. Primary completion14 Oct 2022
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Full crossover; all participants complete all conditions
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672747
Sponsor's protocol ID
0580-18-FB
Other IDs
RF1MH117032
Status last verified
Jul 2024
First submitted
15 Aug 2018
Last updated
31 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Upon completion of the study, de-identified data from this study will be stored in the National Institute of Mental Health's (NIMH) Data Archive.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct-current stimulation (tDCS) in people with Brain Function, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing (time frame: During the 90 minutes following stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03672747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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