DepressionNCT05188248

A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression

A study testing Transcranial direct current stimulation (tDCS) in people with Depression, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Depression
What is being tested?: Transcranial direct current stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2021to 14 Dec 2022
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Aged 18-45
Female
Mild to moderate depression (determined by BDI-II scores of 14-19 and 20-28, respectively)
If taking antidepressants, medication must be stable ≥ 30 days prior to screening

Who cannot join

Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score <85 (to ensure understanding of test procedures)
Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff
Primary psychiatric disorder other than depression (based on MINI)
Primary neurologic condition that would prevent ability to participate (as determined by study clinician).
History of head trauma in the last year
Medical device implants in the head or neck

Show all 10Show fewer

History or current uncontrolled seizure disorder
Current substance abuse disorder
. Pregnant or lactating women
Skin disorder/sensitive skin near stimulation locations

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 100176

Other trials in United States

About this study

Depression and other psychiatric conditions are marked by exaggerated, preferential processing (or attention bias) of negative information relative to neutral or positive information. This depression-related attention bias can be measured using the Dot Probe task and Visual Search, that allow assessment of the degree to which one shows bias toward negative information in the presence of neutral or positive information. A clinically effective treatment for depression is noninvasive brain stimulation with transcranial direct current stimulation (tDCS), targeting the dorsolateral prefrontal cortex (DLPFC), delivered in repeated sessions across a period of time. The study will test the effect of a single session of DLPFC tDCS on attention bias in patients with mild to moderate depression.

Read the detailed description

This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to moderate depression (based on BDI-II score range 14-19 for mild and 20-28 for moderate) to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Subjects may or may not be receiving treatment for mild-moderate depression.

Conditions: Depression
Being tested: Transcranial direct current stimulation (tDCS)
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial direct current stimulation (tDCS)Device
Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)

Study groups in NCT05188248
Study group	Role	What they receive
Female participants with Depression	Experimental	Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Receives: Device: Transcranial direct current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Beck Depression Inventory (BDI-II) Score
Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
Measured: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Anxiety Score
Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety.
Measured: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Sad Score
Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness.
Measured: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Happy Score
Analog Mood Scale (AMS) Happy is a brief measure of positive and negative mood asking "How happy are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of happiness.
Measured: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Change in Analog Mood Scale (AMS) Anxiety Score
Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. The AMS Anxiety will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Anxiety scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less anxiety post-tDCS administration. A negative value indicates increased anxiety post-tDCS administration.
Measured: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Change in Analog Mood Scale (AMS) Sad Score
Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. The AMS Sad will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Sad scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less sadness post-tDCS administration. A negative value indicates increased sadness post-tDCS administration.
Measured: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Change in Normalized Response Time
The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias. For this task, the change in mean response time (the time between display onset and button press) to the target stimulus is measured as the main outcome variable.
Measured: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202114 Dec 2022

First posted12 Jan 2022
Study start15 Dec 2021
Primary completion14 Dec 2022
Study completion14 Dec 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05188248
Sponsor's protocol ID: 21-01461
Status last verified: Dec 2023
First submitted: 17 Dec 2021
Last updated: 10 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

Pilloni G, Cho H, Tian TE, Beringer J, Bikson M, Charvet L. Immediate and Differential Response to Emotional Stimuli Associated With Transcranial Direct Current Stimulation for Depression: A Visual-Search Task Pilot Study. Neuromodulation. 2024 Jun;27(4):759-765. doi: 10.1016/j.neurom.2023.07.006. Epub 2023 Aug 20.
PubMed 37598327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
ClinicalTrials.gov ID: NCT05188248
Acronym / sponsor ID: 21-01461
Conditions: Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 15 Dec 2021 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 12 Jan 2022 (actual)
Results: Posted 10 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Female participants with Depression	Experimental	Device: Transcranial direct current stimulation (tDCS)Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Aged 18-45
Female
Mild to moderate depression (determined by BDI-II scores of 14-19 and 20-28, respectively)
If taking antidepressants, medication must be stable ≥ 30 days prior to screening

Key exclusion criteria (10 listed)

Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score <85 (to ensure understanding of test procedures)
Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff
Primary psychiatric disorder other than depression (based on MINI)
Primary neurologic condition that would prevent ability to participate (as determined by study clinician).
History of head trauma in the last year

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
Transcranial direct current stimulation (tDCS)Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)	Device	Female participants with Depression

Primary outcome

Beck Depression Inventory (BDI-II) Score
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
Analog Mood Scale (AMS) Anxiety Score
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety.
Analog Mood Scale (AMS) Sad Score
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness.
Analog Mood Scale (AMS) Happy Score
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Happy is a brief measure of positive and negative mood asking "How happy are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of happiness.
Change in Analog Mood Scale (AMS) Anxiety Score
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. The AMS Anxiety will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Anxiety scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less anxiety post-tDCS administration. A negative value indicates increased anxiety post-tDCS administration.
Change in Analog Mood Scale (AMS) Sad Score
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. The AMS Sad will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Sad scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less sadness post-tDCS administration. A negative value indicates increased sadness post-tDCS administration.
Change in Normalized Response Time
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias. For this task, the change in mean response time (the time between display onset and button press) to the target stimulus is measured as the main outcome variable.

Results and safety

Results posted to the registry on 10 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Female Participants With Depression	21	21

Primary outcome: Beck Depression Inventory (BDI-II) Score

Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour). Mean (Standard Deviation). Unit: score on a scale

Measure	Female Participants With Depression n = 21
Value	21.29 (5.29)

Primary outcome: Analog Mood Scale (AMS) Anxiety Score

Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour). Mean (Standard Deviation). Unit: score on a scale

Measure	Female Participants With Depression n = 21
Value	7.95 (5.75)

Primary outcome: Analog Mood Scale (AMS) Sad Score

Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour). Mean (Standard Deviation). Unit: score on a scale

Measure	Female Participants With Depression n = 21
Value	7.19 (5.1)

Primary outcome: Analog Mood Scale (AMS) Happy Score

Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour). Mean (Standard Deviation). Unit: score on a scale

Measure	Female Participants With Depression n = 21
Value	11.67 (6.16)

Adverse events

Time frame: Right after the end of the 30-minute tDCS session. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Female Participants With Depression	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37598327Pilloni G, Cho H, Tian TE, Beringer J, Bikson M, Charvet L. Immediate and Differential Response to Emotional Stimuli Associated With Transcranial Direct Current Stimulation for Depression: A Visual-Search Task Pilot Study. Neuromodulation. 2024 Jun;27(4):759-765. doi: 10.1016/j.neurom.2023.07.006. Epub 2023 Aug 20.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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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.

Leigh Charvet, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation (tDCS) in people with Depression, run by NYU Langone Health 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 4 inclusion and 10 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 10 Jan 2024. 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 10 Jan 2024). 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?

Beck Depression Inventory (BDI-II) Score (time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)). The study lists 7 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 NCT05188248, which also lists 1 linked publication.

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 10 Jan 2024.