An interventional study of TDCS - transcranial direct current stimulation in Depression, Anxiety, sponsored by Jay Fournier. Terminated at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Jay Fournier · Not applicable, Interventional, and Other
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 4 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Jay Fournier is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner.
Device: 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.
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.
Time frame: 1 week (between baseline and repeat scanning)
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.
Time frame: 30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days
| Milestone | Sham Transcranial Direct Current Stimulation (tDCS) During fMRI Followed by Active tDCS During fMRI | ActiveTranscranial Direct Current Stimulation (tDCS) During fMRI Followed by Sham tDCS During fMRI |
|---|---|---|
| Started | 3 | 1 |
| Completed | 3 | 0 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| arbitrary units | Active vs Sham Transcranial Direct Current Stimulation During fMRI |
|---|---|
| Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning. | -.09 ± .36 |
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.
| Participants | Active vs Sham Transcranial Direct Current Stimulation During fMRI |
|---|---|
| The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition | 3 |
Collected over 1 day (the day of the scan).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Transcranial Direct Current Stimulation During fMRI | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Sham Transcranial Direct Current Stimulation During fMRI | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Active Transcranial Direct Current Stimulation During fMRI | Sham Transcranial Direct Current Stimulation During fMRI |
|---|---|---|
| Scalp burning/itching/tingling sensationNervous system disorders | 4/4 | 3/3 |
| headacheNervous system disorders | 3/4 | 0/3 |
| Sleepiness/dizzinessNervous system disorders | 3/4 | 1/3 |
| Mood change or difficulty concentratingNervous system disorders | 0/4 | 2/3 |
| tension/anxiety/disorientationNervous system disorders | 2/4 | 0/3 |
| Age, Categorical(Participants) | Both Arms Reported Together. |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Age, Continuous(years) | Both Arms Reported Together. |
|---|---|
| Mean | 23.5 ± 5.3 |
| Sex: Female, Male(Participants) | Both Arms Reported Together. |
|---|---|
| Female | 3 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Both Arms Reported Together. |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Both Arms Reported Together. |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Both Arms Reported Together. |
|---|---|
| United States | 4 |
| Quick Inventory Depressive Symptoms(units on a scale) | Both Arms Reported Together. |
|---|---|
| Mean | 11.0 ± 3.6 |
| PROMIS Anxiety Short Form(units on a scale) | Both Arms Reported Together. |
|---|---|
| Mean | 23.5 ± .6 |
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