Major Depressive DisorderNCT03556124
Transcranial Direct Current Stimulation in Major Depression
A study testing Active - HD tDCS and Active - Conventional tDCS in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active - HD tDCS and Active - Conventional tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 55 years, inclusive
- Gender: all
- Race/ethnicity: all races and ethnic groups
- Capacity to provide informed consent
- Hamilton Rating Scale for Depression (HAMD) score of ≥14 and <24, with or without symptoms of anxiety
- Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic's (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention
- Live within traveling distance to the University of California, Los Angeles (UCLA)
Who cannot join
- Pregnancy
- Non-English speaking
- Current Substance Use Disorder
- Neurological condition associated with brain abnormalities (e.g., traumatic brain injury; recent stroke, tumor)
- Any contraindication to tDCS (e.g., skin disease or treatment causing irritation)
- Any condition that would contraindicate MRI scanning (metal implants, claustrophobia or a breathing or movement disorder)
Show all 18Show fewer
- Currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
- Change in antidepressant medication within 6-weeks of starting the trial
- Severe or treatment resistant depression - HAMD scores > 24 and a history of a major depressive episode lasting >2-years or failure to 2 or more antidepressant trials in the current index episode
- Any neuromodulation therapy (e.g., ECT, transcranial magnetic stimulation (rTMS), tDCS) within the last 3-months
- Current or past (within the last 1-month) use of anticonvulsants, lithium, psychostimulant, dexamphetamine
- Current use of decongestants or other medication including sleeping aids previously shown to interfere with cortical excitability
- Schizophrenia Axis I disorder
- Dementia of any type
- Bipolar I disorder
- Diagnosis of seizure disorder or history of seizures
- Depression related to serious medical illness (i.e., mood disorder due to general medical condition)
- Actively suicidal as defined by a score of 4 on item 3 of HAMD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Official title: Imaging-guided tDCS Therapy in Major Depression
Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms. We will investigate these questions in a two-part randomized double blind exploratory clinical trial. The first part of the trial will compare how current flow and functional imaging signal differs in the brain when using tDCS with more focal stimulation, called high definition (HD) tDCS, compared to conventional tDCS (C-tDCS) or sham (non-active) tDCS in patients with MDD.
Sixty people with depression (20 in each group) will be randomized to receive either HD-tDCS, C-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham tDCS in the MRI scanner, which will allow us to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests
Read the detailed description
Transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, applied to the left dorsolateral prefrontal cortex (DLPFC) can reduce depressive symptoms and improve cognitive control in major depressive disorder (MDD). Such findings suggest modulation of top down prefrontal-limbic circuits, which are functionally distinct from ventro-limbic networks and include reciprocally connected DLPFC and dorsomedial anterior cingulate cortex (dACC). However, substantial variation in tDCS response is observed in MDD. This may be due to imprecise stimulation protocols and suboptimal engagement of the neural circuits mediating antidepressant response. Methods that optimize electrode placement and account for individual variation in anatomy and that map current flow directly in the brain may inform the mechanisms and potential clinical utility of tDCS. A new tDCS technique, high definition (HD) tDCS, offers more focal stimulation than conventional tDCS (C-tDCS). The degree to which C-tDCS or HD-tDCS engage dorsal prefrontal-limbic neural circuits is unknown, yet is vital for understanding, confirming and subsequently improving possible therapeutic effects. Innovative MRI techniques that are able to map tDCS currents in vivo and that track changes in regional cerebral blood flow occurring with tDCS over time can provide direct evidence of neural effects. Based on a) theoretical modeling of tDCS current flow, b) studies showing hypo-metabolism, decreased CBF or activity in dorsal prefrontal-limbic networks, c) modulation of these regions with treatment, and, c) our prior results showing significant relationships in between change in dACC rCBF and clinical response to electroconvulsive therapy (ECT), an established brain stimulation treatment, we will test for the tDCS engagement and modulation of the DLPFC and dACC using tDCS current mapping performed in vivo and perfusion MRI. MRI-guided neuronavigation will be used to optimize and standardize electrode placement for DLPFC stimulation.
In this trial we will test for the target engagement of the DLPFC and dACC by comparing C-tDCS, HD-tDCS and sham tDCS applied to the left DLPFC in patients with moderate to severe MDD before and after they complete 12 daily 20-minute sessions of C-tDCS, HD-tDCS or Sham tDCS (n=20 randomized to each group). In-vivo electric current mapping performed at different current intensities (0-2 mA) for 20-30 minutes, and change in regional cerebral blood flow (rCBF) measured before and after a 12-day tDCS trial will determine acute and longer-term modulation of DLPFC and dACC circuitry for each tDCS modality respectively.
- Conditions
- Major Depressive Disorder
- Being tested
- Active - HD tDCS, Sham - HD tDCS, Active - Conventional tDCS, Sham - Conventional tDCS
- Keywords
- Transcranial direct current stimulation, major depression, MRI
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active - HD tDCSDevice
Non-invasive neuromodulation using HD electrodes placed on the scalp to deliver a constant, low current at 2 mA.
Sham - HD tDCSDevice
Sham neuromodulation using HD electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.
Active - Conventional tDCSDevice
Non-invasive neuromodulation using standard 7 cm x 5 cm electrodes placed on the scalp to deliver a constant, low current at 2 mA.
Sham - Conventional tDCSDevice
Sham neuromodulation using standard 7 cm x 5 cm electrodes electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.
| Study group | Role | What they receive |
|---|---|---|
| Active - HD tDCS | Experimental | Participants randomized to this arm will receive 12 sessions of high definition tDCS (HD-tDCS) stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. Receives: Device: Active - HD tDCS |
| Active - Conventional tDCS | Experimental | Participants randomized to this arm will receive 12 sessions of conventional tDCS (C-tDCS) stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. Receives: Device: Active - Conventional tDCS |
| Sham - HD tDCS | Sham comparator | Participants randomized to this arm will receive 12 sessions of sham HD tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. Receives: Device: Sham - HD tDCS |
| Sham - Conventional tDCS | Sham comparator | Participants randomized to this arm will receive 12 sessions of sham conventional tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. Receives: Device: Sham - Conventional tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in non-invasive MRI measures of cerebral blood flow between baseline and end of treatment
Modulation of the left dorsolateral prefrontal cortex (DLPFC) and dorsal anterior cingulate cortex (dACC) measured by percent rCBF signal change
Measured: Up to 3 weeks
Change in non-invasive MRI measures of current flow
tDCS-induced in vivo magnetic field changes in the left DLPFC as the current is being ramped up from 0 to 2 mA in increments of 0.5 mA over the course of a 1-hour MRI scan
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start2 Feb 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active and Sham controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Katherine Narr, University of California, Los Angeles
- Investigators
- Katherine Narr, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556124
- Sponsor's protocol ID
- 17-000779
- Other IDs
- R61MH110526
- Status last verified
- Jul 2020
- First submitted
- 2 Jun 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jog MA, Anderson C, Kubicki A, Boucher M, Leaver A, Hellemann G, Iacoboni M, Woods R, Narr K. Transcranial direct current stimulation (tDCS) in depression induces structural plasticity. Sci Rep. 2023 Feb 17;13(1):2841. doi: 10.1038/s41598-023-29792-6.
PubMed 36801903Jog M, Anderson C, Kim E, Garrett A, Kubicki A, Gonzalez S, Jann K, Iacoboni M, Woods R, Wang DJ, Narr KL. A novel technique for accurate electrode placement over cortical targets for transcranial electrical stimulation (tES) clinical trials. J Neural Eng. 2021 Oct 11;18(5):10.1088/1741-2552/ac297d. doi: 10.1088/1741-2552/ac297d.
PubMed 34555822
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-guided tDCS Therapy in Major Depression
- ClinicalTrials.gov ID
- NCT03556124
- Acronym / sponsor ID
- 17-000779
- Conditions
- Major Depressive Disorder
- Keywords
- Transcranial direct current stimulation, major depression, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms. We will investigate these questions in a two-part randomized double blind exploratory clinical trial. The first part of the trial will compare how current flow and functional imaging signal differs in the brain when using tDCS with more focal stimulation, called high definition (HD) tDCS, compared to conventional tDCS (C-tDCS) or sham (non-active) tDCS in patients with MDD.
Sixty people with depression (20 in each group) will be randomized to receive either HD-tDCS, C-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham tDCS in the MRI scanner, which will allow us to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests
Detailed description
Transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, applied to the left dorsolateral prefrontal cortex (DLPFC) can reduce depressive symptoms and improve cognitive control in major depressive disorder (MDD). Such findings suggest modulation of top down prefrontal-limbic circuits, which are functionally distinct from ventro-limbic networks and include reciprocally connected DLPFC and dorsomedial anterior cingulate cortex (dACC). However, substantial variation in tDCS response is observed in MDD. This may be due to imprecise stimulation protocols and suboptimal engagement of the neural circuits mediating antidepressant response. Methods that optimize electrode placement and account for individual variation in anatomy and that map current flow directly in the brain may inform the mechanisms and potential clinical utility of tDCS. A new tDCS technique, high definition (HD) tDCS, offers more focal stimulation than conventional tDCS (C-tDCS). The degree to which C-tDCS or HD-tDCS engage dorsal prefrontal-limbic neural circuits is unknown, yet is vital for understanding, confirming and subsequently improving possible therapeutic effects. Innovative MRI techniques that are able to map tDCS currents in vivo and that track changes in regional cerebral blood flow occurring with tDCS over time can provide direct evidence of neural effects. Based on a) theoretical modeling of tDCS current flow, b) studies showing hypo-metabolism, decreased CBF or activity in dorsal prefrontal-limbic networks, c) modulation of these regions with treatment, and, c) our prior results showing significant relationships in between change in dACC rCBF and clinical response to electroconvulsive therapy (ECT), an established brain stimulation treatment, we will test for the tDCS engagement and modulation of the DLPFC and dACC using tDCS current mapping performed in vivo and perfusion MRI. MRI-guided neuronavigation will be used to optimize and standardize electrode placement for DLPFC stimulation.
In this trial we will test for the target engagement of the DLPFC and dACC by comparing C-tDCS, HD-tDCS and sham tDCS applied to the left DLPFC in patients with moderate to severe MDD before and after they complete 12 daily 20-minute sessions of C-tDCS, HD-tDCS or Sham tDCS (n=20 randomized to each group). In-vivo electric current mapping performed at different current intensities (0-2 mA) for 20-30 minutes, and change in regional cerebral blood flow (rCBF) measured before and after a 12-day tDCS trial will determine acute and longer-term modulation of DLPFC and dACC circuitry for each tDCS modality respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Active and Sham controlled
| Arm | Type | Receives |
|---|---|---|
| Active - HD tDCS | Experimental | Device: Active - HD tDCSParticipants randomized to this arm will receive 12 sessions of high definition tDCS (HD-tDCS) stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. |
| Active - Conventional tDCS | Experimental | Device: Active - Conventional tDCSParticipants randomized to this arm will receive 12 sessions of conventional tDCS (C-tDCS) stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. |
| Sham - HD tDCS | Sham comparator | Device: Sham - HD tDCSParticipants randomized to this arm will receive 12 sessions of sham HD tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. |
| Sham - Conventional tDCS | Sham comparator | Device: Sham - Conventional tDCSParticipants randomized to this arm will receive 12 sessions of sham conventional tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 to 55 years, inclusive
- Gender: all
- Race/ethnicity: all races and ethnic groups
- Capacity to provide informed consent
- Hamilton Rating Scale for Depression (HAMD) score of ≥14 and <24, with or without symptoms of anxiety
Key exclusion criteria (18 listed)
- Pregnancy
- Non-English speaking
- Current Substance Use Disorder
- Neurological condition associated with brain abnormalities (e.g., traumatic brain injury; recent stroke, tumor)
- Any contraindication to tDCS (e.g., skin disease or treatment causing irritation)
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 |
|---|---|---|
| Active - HD tDCSNon-invasive neuromodulation using HD electrodes placed on the scalp to deliver a constant, low current at 2 mA. | Device | Active - HD tDCS |
| Sham - HD tDCSSham neuromodulation using HD electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec. | Device | Sham - HD tDCS |
| Active - Conventional tDCSNon-invasive neuromodulation using standard 7 cm x 5 cm electrodes placed on the scalp to deliver a constant, low current at 2 mA. | Device | Active - Conventional tDCS |
| Sham - Conventional tDCSSham neuromodulation using standard 7 cm x 5 cm electrodes electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec. | Device | Sham - Conventional tDCS |
Primary outcome
Changes in non-invasive MRI measures of cerebral blood flow between baseline and end of treatment
Time frame: Up to 3 weeks
Modulation of the left dorsolateral prefrontal cortex (DLPFC) and dorsal anterior cingulate cortex (dACC) measured by percent rCBF signal change
Change in non-invasive MRI measures of current flow
Time frame: 1 hour
tDCS-induced in vivo magnetic field changes in the left DLPFC as the current is being ramped up from 0 to 2 mA in increments of 0.5 mA over the course of a 1-hour MRI scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Derived from this study: PubMed 36801903Jog MA, Anderson C, Kubicki A, Boucher M, Leaver A, Hellemann G, Iacoboni M, Woods R, Narr K. Transcranial direct current stimulation (tDCS) in depression induces structural plasticity. Sci Rep. 2023 Feb 17;13(1):2841. doi: 10.1038/s41598-023-29792-6.
- Derived from this study: PubMed 34555822Jog M, Anderson C, Kim E, Garrett A, Kubicki A, Gonzalez S, Jann K, Iacoboni M, Woods R, Wang DJ, Narr KL. A novel technique for accurate electrode placement over cortical targets for transcranial electrical stimulation (tES) clinical trials. J Neural Eng. 2021 Oct 11;18(5):10.1088/1741-2552/ac297d. doi: 10.1088/1741-2552/ac297d.
- Individual participant dataSharing planned: No
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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.
Katherine Narr, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active - HD tDCS and Active - Conventional tDCS in people with Major Depressive Disorder, run by University of California, Los Angeles 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 31 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in non-invasive MRI measures of cerebral blood flow between baseline and end of treatment (time frame: Up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556124, which also lists 2 linked publications.
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 31 Jul 2020.