Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I

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: NCT03672747
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tony W. Wilson, PhD, University of Nebraska

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

Condition or disease Intervention/treatment Phase
How Occipital tDCS Affects Brain Function in Healthy Adults Device: transcranial direct-current stimulation (tDCS) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Full crossover; all participants complete all conditions
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Basic Science
Official Title: The Impact of Spontaneous Cortical Activity on Neural Oscillations and Behavioral Performance: Evidence From High-definition tDCS and MEG
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Active Comparator: Anodal
Participants will receive occipital anodal stimulation using high-definition tDCS
Device: transcranial direct-current stimulation (tDCS)
20 minutes duration using high-definition system with center-surround configuration
Other Name: Transcranial electrical stimulation

Active Comparator: Cathodal
Participants will receive occipital cathodal stimulation using high-definition tDCS
Device: transcranial direct-current stimulation (tDCS)
20 minutes duration using high-definition system with center-surround configuration
Other Name: Transcranial electrical stimulation

Placebo Comparator: Sham
Participants will receive occipital sham stimulation (placebo) using high-definition tDCS
Device: transcranial direct-current stimulation (tDCS)
20 minutes duration using high-definition system with center-surround configuration
Other Name: Transcranial electrical stimulation




Primary Outcome Measures :
  1. Behavioral performance on cognitive tests of attention and perceptual processing [ Time Frame: During the 90 minutes following stimulation ]
    Do participants perform better in terms of accuracy and/or reaction time following occipital tDCS on behavioral measures (e.g., the Flanker task) of attention function and/or perceptual processing.


Secondary Outcome Measures :
  1. The power of spontaneous neural activity as quantified by MEG imaging [ Time Frame: During the 90 minutes following stimulation ]
    Does spontaneous alpha (9-13 Hz) and/or gamma (45-80 Hz) power, as measured by MEG, get stronger in the occipital cortices following tDCS.

  2. The power of oscillatory neural activity as quantified by MEG imaging [ Time Frame: During the 90 minutes following stimulation ]
    Does oscillatory alpha and/or gamma neural activity, as measured by MEG, get stronger in the occipital cortices following tDCS.



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:   19 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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: 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 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 orthodonture, which may interfere with the MEG data acquisition and/or be anMRI 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).

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): NCT03672747


Contacts
Layout table for location contacts
Contact: Tony W Wilson, PhD 4025526431 twwilson@unmc.edu
Contact: Elizabeth Heinrichs-Graham, PhD 402-552-6433 e.heinrichsgraham@unmc.edu

Locations
Layout table for location information
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Rebecca Losh, BA    402-552-6436    rebecca.losh@unmc.edu   
Principal Investigator: Tony W Wilson, PhD         
Sponsors and Collaborators
University of Nebraska
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Tony W Wilson, PhD University of Nebraska

Layout table for additonal information
Responsible Party: Tony W. Wilson, PhD, Associate Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03672747     History of Changes
Other Study ID Numbers: 580-18-FB
RF1MH117032 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: Data will be fully update by the end of the study and will remain publicly available indefinitely.
Access Criteria: Approval/Account from the NIMH

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No