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| ID | Type | Description | Link |
|---|---|---|---|
| RF1MH117032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal Brain Stimulation | Active Comparator | Participants will receive anodal stimulation using high-definition tDCS |
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| Cathodal Brain Stimulation | Active Comparator | Participants will receive cathodal stimulation using high-definition tDCS |
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| Sham Brain Stimulation (Placebo) | Sham Comparator | Participants will receive sham stimulation (placebo) using high-definition tDCS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct-current stimulation (tDCS) | Device | 20 minutes duration using high-definition system with center-surround configuration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony W Wilson, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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.
Data will be fully updated by the end of the study and will remain publicly available indefinitely.
Approval/Account from the NIMH
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Note that 133 participants were enrolled using a cross-over design and randomized into one of six tracks. There was at least a 7 day washout between each of the three visits and this was the same across the six tracks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anodal Stimulation, Then Cathodal Stimulation, Then Sham | Participants received 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. |
| FG001 | Anodal Stimulation, Then Sham Stimulation, Then Cathodal Stimulation | Participants received 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. |
| FG002 | Cathodal Stimulation, Then Anodal Stimulation, Then Sham | Participants received 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. |
| FG003 | Cathodal Stimulation, Then Sham, Then Anodal Stimulation | Participants received 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of sham stimulation using HD-tDCS. At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. |
| FG004 | Sham Stimulation, Then Anodal Stimulation, Then Cathodal Stimulation | Participants received 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. |
| FG005 | Sham Stimulation, Then Cathodal Stimulation, Then Anodal Stimulation | Participants received 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (HD-tDCS). At least seven days later, they received 20 minutes of cathodal stimulation using HD-tDCS. At least seven days later, they received 20 minutes of anodal stimulation using HD-tDCS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants received all interventions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data. | Posted | Mean | Standard Deviation | percent correct | During the 90 minutes following stimulation |
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Each participant was in the study for about one month (4 weeks).
Standard definitions for adverse events were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anodal Stimulation | Participants will receive 20 minutes of anodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration |
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Focus on single stimulation amplitude and duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tony Wilson | Boys Town National Research Hospital | 531-355-8909 | tony.w.wilson@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2023 | May 19, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Full crossover; all participants complete all conditions
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Double-blinded
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| 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. | 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. | 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. | During the 90 minutes following stimulation |
| Participants |
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| Age, Continuous | Age at enrollment in years; self-reported | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mental health questionnaire | This was a 20 item pass/fail screener for psychiatric disease and cognitive impairment; participants had to pass screen ruling out psychiatric disease and cognitive impairment to be included in the study. If they endorsed being previously diagnosed with any psychiatric or neurological condition, including substance use disorders, they were excluded from the study. In total, 133 participants passed the screener and started the full study. However, only 124 completed all study aspects and participants had to complete all aspects to be included in the final analyses. | Count of Participants | Participants |
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| OG002 | Sham Stimulation (Placebo) | Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration |
|
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| Secondary | 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. | 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data. | Posted | Mean | Standard Error | nano-amperes square (nA^2) | During the 90 minutes following stimulation |
|
|
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| Secondary | 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. | 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data. | Posted | Mean | Standard Error | percent increase/decrease from baseline | During the 90 minutes following stimulation |
|
|
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| Primary | 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. | 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data. | Posted | Mean | Standard Deviation | milliseconds | During the 90 minutes following stimulation |
|
|
|
| Secondary | 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. | 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data. | Posted | Mean | Standard Error | nano-amperes square (nA^2) | During the 90 minutes following stimulation |
|
|
|
| Secondary | 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. | 124 participants completed all three conditions (anodal, cathodal, sham) and have evaluable data. | Posted | Mean | Standard Error | percent increase/decrease from baseline | During the 90 minutes following stimulation |
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|
| 0 |
| 133 |
| 0 |
| 133 |
| 0 |
| 133 |
| EG001 | Cathodal Stimulation | Participants will receive 20 minutes of cathodal stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration | 0 | 133 | 0 | 133 | 0 | 133 |
| EG002 | Sham Stimulation (Placebo) | Participants will receive 20 minutes of sham stimulation using high-definition transcranial direct-current stimulation (tDCS) with center-surround configuration | 0 | 133 | 0 | 133 | 0 | 133 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |