Depression, AnxietyMDMNNCT04598152
Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study
A study testing TDCS - transcranial direct current stimulation in people with Depression, Anxiety, run by Jay Fournier at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- TDCS - transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-30years old
- Score > 10 on the QIDS or > 60 on the PROMIS-A
- We will use a flexible extreme groups recruitment strategy to ensure an adequate distribution of ESC scores. We will ensure that at least 62% of the sample will be composed of those scoring .5 SD above or below the mean, as measured by the NEO-PI-R. This value corresponds to the expected values assuming a normal distribution of the trait.
- Normal or corrected to normal vision with contact lenses
- Able to provide informed consent in English
- Right-handed (Annett criteria)
Who cannot join
- Have a history of head trauma with loss of consciousness.
- Have a systemic medical illness that may impact fMRI measures of cerebral blood flow.
- Meet standard exclusion criteria for fMRI scanning (e.g. claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other MRI non-safe metal objects in the body).
- Are pregnant (self report and tested for as part of any scan by the scanning center and not this protocol)
- Not native English speaking or not fluent
- Premorbid NAART IQ estimate<85;
Show all 14Show fewer
- Visual disturbance (worse than 20/40 Snellen visual acuity) that is not corrected
- If have visual disturbance, only access to correction with glasses (i.e., no access to contact lenses).
- Left/mixed handedness (Annett criteria), to ensure a uniform hemispheric dominance for interpretation of neuroimaging data
- Active suicidal ideation in need of immediate treatment
- Scoring below the cutoffs on both the QIDS and the PROMIS-A
- History of alcohol/substance use disorder (including nicotine) and/or illicit substance use (except cannabis) over the last 3 months, determined by the MINI. Lifetime/present cannabis use (non-disordered levels) will be allowed, given its common usage in individuals in this age range.
- Current or past psychotic-spectrum disorder
- History of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
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.
- Conditions
- Depression, Anxiety
- Being tested
- TDCS - transcranial direct current stimulation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCS - transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TDCS - transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week (between baseline and repeat scanning)
Secondary outcomes (1)
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.
Measured: 30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Why it stopped: Covid restrictions prevented continuation during the funding window
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jay Fournier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jay Fournier, University of Pittsburgh
- Investigators
- Jay C Fournier, Ph. D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598152
- Sponsor's protocol ID
- STUDY19090112
- Acronym
- MDMN
- Status last verified
- Dec 2021
- First submitted
- 10 Oct 2020
- Last updated
- 4 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study
- ClinicalTrials.gov ID
- NCT04598152
- Acronym / sponsor ID
- MDMN / STUDY19090112
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid restrictions prevented continuation during the funding window
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jay FournierUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 4 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation during fMRI | Experimental | Device: TDCS - transcranial direct current stimulationEach subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18-30years old
- Score > 10 on the QIDS or > 60 on the PROMIS-A
- We will use a flexible extreme groups recruitment strategy to ensure an adequate distribution of ESC scores. We will ensure that at least 62% of the sample will be composed of those scoring .5 SD above or below the mean, as measured by the NEO-PI-R. This value corresponds to the expected values assuming a normal distribution of the trait.
- Normal or corrected to normal vision with contact lenses
- Able to provide informed consent in English
Key exclusion criteria (14 listed)
- Have a history of head trauma with loss of consciousness.
- Have a systemic medical illness that may impact fMRI measures of cerebral blood flow.
- Meet standard exclusion criteria for fMRI scanning (e.g. claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other MRI non-safe metal objects in the body).
- Are pregnant (self report and tested for as part of any scan by the scanning center and not this protocol)
- Not native English speaking or not fluent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDCS - transcranial direct current stimulationTDCS 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. | Device | Transcranial Direct Current Stimulation during fMRI |
Primary outcome
Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning.
Time frame: 1 week (between baseline and repeat 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 secondary outcome
The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition
Time frame: 30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay C Fournier, Ph. D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDCS - transcranial direct current stimulation in people with Depression, Anxiety, run by Jay Fournier at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning. (time frame: 1 week (between baseline and repeat scanning)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.