Clinical trial NCT05263440: Immediate Effects of DLPFC tDCS on Attention Bias
Official title: A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: New York University
First posted: 2022-03-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Level of Depression before Transcranial direct current stimulation (tDCS)
timeFrame: Study tDCS Administration Visit (Day1)
measure: Level of Anxiety before Transcranial direct current stimulation (tDCS)
timeFrame: Study tDCS Administration Visit (Day1)
measure: Intensity level of Depressive Symptoms
timeFrame: Study tDCS Administration Visit (Day1)
measure: Intensity level of Depressive Symptoms using SMDDS
timeFrame: Study tDCS Administration Visit (Day1)
measure: Change in the negative affect after Transcranial direct current stimulation (tDCS)
timeFrame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
measure: Change in the negative mood after Transcranial direct current stimulation (tDCS)
timeFrame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
measure: Change in attention bias using the Dot Probe task
timeFrame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
measure: Change in attention bias using the Visual Search task
timeFrame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Kyrana Tsapkini, PhD
role: PRINCIPAL_INVESTIGATOR
References: