DepressionNCT05263440
Immediate Effects of DLPFC tDCS on Attention Bias
A study testing Transcranial direct current stimulation (tDCS) in people with Depression, run by Johns Hopkins University.
Trial summary
This research is being done to test if the investigators can modify or reduce negative attention bias in depression following a single session of transcranial direct current stimulation (tDCS) over the left anodal dorsolateral prefrontal cortex (DLPFC) in patients with mild to severe depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-45
- Female
- Mild to severe depression (determined by BDI-II scores of 14-19 and 29-63, 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
About this study
Official title: A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
This research is being done to test if the investigators can modify or reduce negative attention bias in depression following a single session of transcranial direct current stimulation (tDCS) over the left anodal dorsolateral prefrontal cortex (DLPFC) in patients with mild to severe depression. The study will consist of a single-session tDCS session administered onsite at the Johns Hopkins University (JHU). After the consent process, participants will complete the study (approximately one hour in duration) with the guidance of a research associate.
Read the detailed description
This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to severe depression (based on BDI-II score range 14-19 for mild and 29-63 for severe) 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-severe 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 group | Role | What they receive |
|---|---|---|
| Experimental: Female participants with Depression | Experimental | Female participants with mild to severe 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.
Level of Depression before Transcranial direct current stimulation (tDCS)
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.
Measured: Study tDCS Administration Visit (Day1)
Level of Anxiety before Transcranial direct current stimulation (tDCS)
Measured by the Beck Anxiety Inventory (BAI) which is a brief, criteria-referenced assessment for measuring anxiety severity and level. Participants respond to 21 items rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. BAI has been found to discriminate well between anxious and non-anxious diagnostic groups in a variety of clinical populations.
Measured: Study tDCS Administration Visit (Day1)
Intensity level of Depressive Symptoms
Measured by the Hamilton Depression Rating Scale (HAM-D) which is a 17-item measure that was designed to assess frequency and intensity of depressive symptoms in patients with Major Depressive Disorder (MDD). This measure contains somatic and suicidal ideation items and has demonstrated reliability, validity, and efficiency in adult populations
Measured: Study tDCS Administration Visit (Day1)
Intensity level of Depressive Symptoms using SMDDS
The Symptoms of Major Depressive Disorder Scale (SMDDS) is a brief self reported measure for adults with MDD and measures specific symptom dimensions. The qualitative measure has good psychometric properties including high reliability and validity.
Measured: Study tDCS Administration Visit (Day1)
Change in the negative affect after Transcranial direct current stimulation (tDCS)
The Positive and Negative Affect Schedule (PANAS-SF) will be administered before and after the Transcranial direct current stimulation (tDCS) session. This is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect.
Measured: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Change in the negative mood after Transcranial direct current stimulation (tDCS)
Will be assessed by using the Analog Mood Scale (AMS). This is a brief measure of positive and negative mood consisting of three questions (i.e., "How anxious are you?", "How sad are you?", and "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).
Measured: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Change in attention bias using the Dot Probe task
The dot-probe task will be used to assess depression-related attention bias before and after tDCS administration.To complete the Dot-Probe task, participants will be shown two emotional images (e.g., sad and neutral pair or happy and neutral pair) simultaneously followed by a target in the location of one of the emotional images. Response latencies to targets replacing either the negative/positive or neutral images will be measured before and after training which will be the primary study outcome.
Measured: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Change in attention bias using the Visual Search task
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 alongside the Dot Probe task. For this task, mean response time (the time between display onset and button press) to the target stimulus for each stimulus type 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.
- First posted2 Mar 2022
- Study start1 Mar 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: The study never started because one of the collaborators was not able to attend to the study requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Sponsor
- Investigators
- Kyrana Tsapkini, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263440
- Sponsor's protocol ID
- IRB00312231
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. 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
- NCT05263440
- Acronym / sponsor ID
- IRB00312231
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started because one of the collaborators was not able to attend to the study requirements.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- New York University
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
This research is being done to test if the investigators can modify or reduce negative attention bias in depression following a single session of transcranial direct current stimulation (tDCS) over the left anodal dorsolateral prefrontal cortex (DLPFC) in patients with mild to severe depression. The study will consist of a single-session tDCS session administered onsite at the Johns Hopkins University (JHU). After the consent process, participants will complete the study (approximately one hour in duration) with the guidance of a research associate.
Detailed description
This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to severe depression (based on BDI-II score range 14-19 for mild and 29-63 for severe) 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-severe depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Female participants with Depression | Experimental | Device: Transcranial direct current stimulation (tDCS)Female participants with mild to severe 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
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-45
- Female
- Mild to severe depression (determined by BDI-II scores of 14-19 and 29-63, 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 | Experimental: Female participants with Depression |
Primary outcome
Level of Depression before Transcranial direct current stimulation (tDCS)
Time frame: Study tDCS Administration Visit (Day1)
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.
Level of Anxiety before Transcranial direct current stimulation (tDCS)
Time frame: Study tDCS Administration Visit (Day1)
Measured by the Beck Anxiety Inventory (BAI) which is a brief, criteria-referenced assessment for measuring anxiety severity and level. Participants respond to 21 items rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. BAI has been found to discriminate well between anxious and non-anxious diagnostic groups in a variety of clinical populations.
Intensity level of Depressive Symptoms
Time frame: Study tDCS Administration Visit (Day1)
Measured by the Hamilton Depression Rating Scale (HAM-D) which is a 17-item measure that was designed to assess frequency and intensity of depressive symptoms in patients with Major Depressive Disorder (MDD). This measure contains somatic and suicidal ideation items and has demonstrated reliability, validity, and efficiency in adult populations
Intensity level of Depressive Symptoms using SMDDS
Time frame: Study tDCS Administration Visit (Day1)
The Symptoms of Major Depressive Disorder Scale (SMDDS) is a brief self reported measure for adults with MDD and measures specific symptom dimensions. The qualitative measure has good psychometric properties including high reliability and validity.
Change in the negative affect after Transcranial direct current stimulation (tDCS)
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
The Positive and Negative Affect Schedule (PANAS-SF) will be administered before and after the Transcranial direct current stimulation (tDCS) session. This is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect.
Change in the negative mood after Transcranial direct current stimulation (tDCS)
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Will be assessed by using the Analog Mood Scale (AMS). This is a brief measure of positive and negative mood consisting of three questions (i.e., "How anxious are you?", "How sad are you?", and "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).
Change in attention bias using the Dot Probe task
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
The dot-probe task will be used to assess depression-related attention bias before and after tDCS administration.To complete the Dot-Probe task, participants will be shown two emotional images (e.g., sad and neutral pair or happy and neutral pair) simultaneously followed by a target in the location of one of the emotional images. Response latencies to targets replacing either the negative/positive or neutral images will be measured before and after training which will be the primary study outcome.
Change in attention bias using the Visual Search task
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 alongside the Dot Probe task. For this task, mean response time (the time between display onset and button press) to the target stimulus for each stimulus type is measured as the main outcome variable.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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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.
Kyrana Tsapkini, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Depression, run by Johns Hopkins University.
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: withdrawn, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Level of Depression before Transcranial direct current stimulation (tDCS) (time frame: Study tDCS Administration Visit (Day1)). The study lists 8 primary outcomes in all. 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 5 Feb 2025.