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Covid restrictions prevented continuation during the funding window
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The primary purpose of this research is to gather scientific information about how different people's brains work when they look at different types of pictures. This will help to improve the investigators' understanding of the way the brain works for people who are depressed or anxious, and this knowledge could help lead to better diagnosis and treatment.
In this study the investigators are examining the effects of weak electrical stimulation on brain activity as measured by functional magnetic resonance imaging (fMRI). MRI is a widely used method to obtain high resolution brain pictures that are routinely used for diagnostic and clinical purposes. The electrical stimulation is applied on the scalp with a non-FDA approved method called tDCS (transcranial Direct Current Stimulation), typically equivalent to what a 6V battery would produce (and up to no more than 15V). To compare, an AA battery delivers current at 1.5 volt. While almost unnoticeable to the participants, these currents can still temporarily affect brain activity without causing adverse effects. This stimulation would be applied while the participants are in the MRI scanner so that the brain activity can be measured. The participants will have the opportunity to have a test session with the stimulation outside the scanner to get familiar with it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation during fMRI | Experimental | Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDCS - transcranial direct current stimulation | Device | TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning. | The investigators will determine the effects of TDCS on BOLD response in the precuneus/posterior cingulate gyrus. The BOLD signal is a measure of regional blood flow in the brain and is used as a proxy for neural activity in specific brain regions. Values below represent pre-post change in BOLD response to the emotion regulation task that participants complete during fMRI scanning. We hypothesize that tDCS applied to the target used in this study will decrease BOLD signal (lower values) during critical components of this task, normalizing function in this region. | 1 week (between baseline and repeat scanning) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition | Potential side effects (e.g., headaches, dizziness, uncomfortable sensations, etc...) will be assessed after each tDCS and sham-tDCS administration. Side effects were assessed using a standardized form. Count below represents the number of participants who reported a mild or moderate side effect during active tDCS but not sham tDCS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay C Fournier, Ph. D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Transcranial Direct Current Stimulation (tDCS) During fMRI Followed by Active tDCS During fMRI | Each subject will first undergo sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive active tDCS during the task in the scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. |
| FG001 | ActiveTranscranial Direct Current Stimulation (tDCS) During fMRI Followed by Sham tDCS During fMRI | Each subject will first undergo active transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive sham tDCS during the task in the scanner. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Both Arms Reported Together. | Because only 1 participant entered in the real followed by sham condition, we report baseline variables combined across the arms. All 4 participants received active tDCS. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning. | The investigators will determine the effects of TDCS on BOLD response in the precuneus/posterior cingulate gyrus. The BOLD signal is a measure of regional blood flow in the brain and is used as a proxy for neural activity in specific brain regions. Values below represent pre-post change in BOLD response to the emotion regulation task that participants complete during fMRI scanning. We hypothesize that tDCS applied to the target used in this study will decrease BOLD signal (lower values) during critical components of this task, normalizing function in this region. | Because no subjects completed the Active followed by Sham tDCS arm, results are reported for the 3 individuals who completed the Sham followed by Active tDCS arm only. | Posted | Mean | Standard Deviation | arbitrary units | 1 week (between baseline and repeat scanning) |
|
1 day (the day of the scan).
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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 | Active Transcranial Direct Current Stimulation During fMRI | Each subject will undergo both active and sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham tDCS in a randomized crossover design. The critical determinant of adverse events due to tDCS is the number reported during the active tDCS condition compared to those reported during the sham tDCS condition. As such, only one "arm" is reported, and it represents the number of events reported during active tDCS that were not reported by the same individual(s) during sham tDCS. 4 cases are reported (rather than 3) out of abundance of caution as one individual received only active tDCS and was lost to follow-up and so could not contribute the necessary data for the primary or secondary outcomes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | headache | Systematic Assessment |
This study was closed due to Covid 19 restrictions. Only 3 people completed the protocol. No conclusions should be drawn from the results reported. Because of the low sample size, no statistical analyses were undertaken.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Fournier, PhD | The Ohio State University College of Medicine | 614-293-9600 | jay.fournier@osumc.edu |
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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 | Nov 24, 2020 | Aug 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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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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The first part of the study consists of screening procedures that are meant to determine if potential participants are eligible to take part in the remainder of the study.
If you qualify to take part in the scanning portion of the study, you will have 2 scanning sessions on separate days approximately a week apart. For each scan session you will undergo a functional Magnetic Resonance Imaging (fMRI) scan that lasts approximately 30 minutes and no more than 1 hour. The total time you will spend for each scan session will be between 1-3 hours.
During the scanning session you will receive transcranial direct current stimulation (tDCS). Prior to scanning, sponge-electrodes will be placed on your scalp. These electrodes will be connected to a stimulator. This stimulator will apply weak currents to the brain while the MRI takes pictures of your brain's responses. The stimulation current that you will experience is usually less than a 6-volt battery but may be increased up to 15-volts.
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|
| 30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Quick Inventory Depressive Symptoms | Range: 0-27. High scores represent more severe depression. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Anxiety Short Form | Range:7-35. Higher scores represent more severe anxiety | Mean | Standard Deviation | units on a scale |
|
Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham treatment in a randomized crossover design. The outcome of interest is the within-person difference in BOLD response between the active and sham tDCS administrations. As such, only one "arm" is reported. |
|
|
| Secondary | The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition | Potential side effects (e.g., headaches, dizziness, uncomfortable sensations, etc...) will be assessed after each tDCS and sham-tDCS administration. Side effects were assessed using a standardized form. Count below represents the number of participants who reported a mild or moderate side effect during active tDCS but not sham tDCS. | Because no subjects completed the Active followed by Sham tDCS arm, results are reported for the 3 individuals who completed the Sham followed by Active tDCS arm only. | Posted | Count of Participants | Participants | 30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Sham Transcranial Direct Current Stimulation During fMRI | Each subject will undergo both active and sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham tDCS in a randomized crossover design. The critical determinant of adverse events due to tDCS is the number reported during the active tDCS condition compared to those reported during the sham tDCS condition. As such, only one "arm" is reported, and it represents the number of events reported during active tDCS that were not reported by the same individual(s) during sham tDCS. 4 cases are reported (rather than 3) out of abundance of caution as one individual received only active tDCS and was lost to follow-up and so could not contribute the necessary data for the primary or secondary outcomes. | 0 | 3 | 0 | 3 | 3 | 3 |
| Scalp burning/itching/tingling sensation | Nervous system disorders | Systematic Assessment |
|
| Sleepiness/dizziness | Nervous system disorders | Systematic Assessment |
|
| tension/anxiety/disorientation | Nervous system disorders | Systematic Assessment | self-reported increase in tension, anxiety, and/or disorientation |
|
| Mood change or difficulty concentrating | Nervous system disorders | Systematic Assessment | Self-reported mood change and/or difficulties concentrating. |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |