An interventional study of transcranial direct-current stimulation (tDCS) in Brain Function, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by University of Nebraska · Not applicable, Interventional, and Basic science
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
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.
University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
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Exclusion Criteria:
Participants will receive anodal stimulation using high-definition tDCS
Device: transcranial direct-current stimulation (tDCS)
Participants will receive cathodal stimulation using high-definition tDCS
Device: transcranial direct-current stimulation (tDCS)
Participants will receive sham stimulation (placebo) using high-definition tDCS
Device: transcranial direct-current stimulation (tDCS)
20 minutes duration using high-definition system with center-surround configuration
Also known as: Transcranial electrical stimulation
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.
Time frame: 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.
Time frame: During the 90 minutes following stimulation
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.
Time frame: During the 90 minutes following stimulation
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.
Time frame: During the 90 minutes following stimulation
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.
Time frame: During the 90 minutes following stimulation
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.
Time frame: During the 90 minutes following stimulation
| Milestone | Anodal Stimulation, Then Cathodal Stimulation, Then Sham | Anodal Stimulation, Then Sham Stimulation, Then Cathodal Stimulation | Cathodal Stimulation, Then Anodal Stimulation, Then Sham | Cathodal Stimulation, Then Sham, Then Anodal Stimulation | Sham Stimulation, Then Anodal Stimulation, Then Cathodal Stimulation | Sham Stimulation, Then Cathodal Stimulation, Then Anodal Stimulation |
|---|---|---|---|---|---|---|
| Started | 22 | 22 | 22 | 23 | 22 | 22 |
| Completed | 21 | 21 | 20 | 21 | 20 | 21 |
| Not completed | 1 | 1 | 2 | 2 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 | 2 | 2 | 1 |
Do participants perform better in terms of accuracy following tDCS on behavioral measures of perceptual processing.
| percent correct | Anodal Stimulation | Cathodal Stimulation | Sham Stimulation (Placebo) |
|---|---|---|---|
| Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing | 97 ± 1.26 | 98 ± 1.05 | 98 ± .94 |
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.
| nano-amperes square (nA^2) | Anodal Stimulation | Cathodal Stimulation | Sham Stimulation (Placebo) |
|---|---|---|---|
| The Power of Spontaneous Alpha Activity as Quantified by MEG Imaging | 23.26 ± 3.06 | 15.88 ± 2.18 | 17.02 ± 2.46 |
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.
| percent increase/decrease from baseline | Anodal Stimulation | Cathodal Stimulation | Sham Stimulation (Placebo) |
|---|---|---|---|
| The Power of Oscillatory Alpha Activity as Quantified by MEG Imaging | -27.34 ± 3.18 | -26.10 ± 3.03 | -30.88 ± 5.11 |
Do participants perform better in terms of reaction time following tDCS on behavioral measures of perceptual processing.
| milliseconds | Anodal Stimulation | Cathodal Stimulation | Sham Stimulation (Placebo) |
|---|---|---|---|
| Behavioral Performance (Reaction Time) on Cognitive Tests of Perceptual Processing | 713 ± 67 | 708 ± 58 | 724 ± 52 |
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.
| nano-amperes square (nA^2) | Anodal Stimulation | Cathodal Stimulation | Sham Stimulation (Placebo) |
|---|---|---|---|
| The Power of Spontaneous Gamma Activity as Quantified by MEG Imaging | 3.46 ± 1.74 | 3.30 ± 1.89 | 2.43 ± 1.55 |
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.
| percent increase/decrease from baseline | Anodal Stimulation | Cathodal Stimulation | Sham Stimulation (Placebo) |
|---|---|---|---|
| The Power of Oscillatory Gamma Activity as Quantified by MEG Imaging | 10.78 ± 2.74 | 6.35 ± 1.98 | 6.28 ± 1.87 |
Collected over Each participant was in the study for about one month (4 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anodal Stimulation | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
| Cathodal Stimulation | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
| Sham Stimulation (Placebo) | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
Of the 133 enrolled, 124 participants completed all interventions. The order of interventions was balanced and the goal was to identify the impact of the intervention and eliminate any effect of administration order.
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 103 |
| >=65 years | 21 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 44 (20 to 72) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 65 |
| Male | 59 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 110 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 12 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 101 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 124 |
| Mental health questionnaire(Participants) | All Study Participants |
|---|---|
| Count of participants | 124 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: 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
Ran from Feb 2019 to primary completion in Oct 2022, 43 months.
Results were first posted in Jul 2024, 1 year 9 months after primary completion.
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