MRI-Guided High-Definition Transcranial Direct Current Stimulation (tDCS) for Depression

Depression Clinical Trial

Official title:

Applied Strategies for MRI-Guided High-Definition tDCS for Major Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090397
• Other study ID #: STU00213826
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with major depression measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.

Description:

This is an investigator-initiated MRI research study of a noninvasive neurostimulation technique, transcranial direct current stimulation (tDCS) using focal "high definition" (HD) electrodes positioned using pre-treatment MRI. Primary objective is to measure changes in brain function during MRI-guided HDtDCS with MRI. Secondary objective is to measure changes in depressive symptoms after five consecutive days of MRI-guided tDCS (20 minutes per session).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1. Ages between 18 and 65
• 2. Race/ethnicity: all races and ethnic groups
• 3. Sex/Gender: all
• 4. Capacity to provide informed consent
• 5. Diagnosis of Major Depressive Disorder made by volunteer's physician at least one year prior (confirmed by patient self-report)
• 6. Currently under the care of a clinician for depression (psychiatrist, psychologist, or other clinician)
• 7. Currently experiencing symptoms of depression (Patient Health Questionnaire 9, PHQ9 >4 at screening; Hamilton Depression Rating Scale 17-item, HDRS-17, score >8 at Visit 1)
• 8. Stable or no pharmacological antidepressant regimen (SSRI, SNRI, MOAI, or tricyclic/TCA) with no change in treatment 6 weeks prior to study start

Exclusion Criteria:

• 1. Ages below 18 (neurobiology is quite different in children vs. adults)
• 2. Ages above 65 (cortical excitability changes with age)
• 3. Active suicidal thoughts, ideation, or behavior with plan within the past month (HDRS-17 item 3 score 3-4)
• 4. Change in antidepressant medication within 6 weeks of study start
• 5. Diagnosis of any medical condition potentially affecting brain function:

neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, primary anxiety disorder, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence within past 12 months, chronic pain (current, or for more than one year within the past one year), other major medical conditions (e.g., cancer, stroke).

• 6. MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
• 7. tES contraindications: skin conditions or injuries on the scalp hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI)
• 8. Non-English speakers (due to written consent and questionnaires administered)
• 9. Neurostimulation or neuromodulation treatment for any reason within the past 3 months
• 10. Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics.
• 11. Prisoners will not participate in this study.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
• Sham Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation

Locations

Country	Name	City	State
United States	CTI Northwestern	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in brain functional connectivity	Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).	Acute/immediate
Secondary	Changes in depressive symptoms (Hamilton)	Symptoms of depression will be measured before and after 5 sessions of tDCS using Hamilton Depression Rating Scale (HDRS 17-item). Change HDRS score will be used as a secondary outcome measure. Score range is 0-53, where low scores indicate low symptoms.	1 week, 2 weeks, 1 month
Secondary	Changes in depressive symptoms (Beck)	Symptoms of depression will be measured before and after 5 sessions of tDCS using Beck Depression Inventory (BDI). Change BDI score will be used as a secondary outcome measure. Score range is 0-62, where low scores indicate low symptoms.	1 week, 2 weeks, 1 month