- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06236711
Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)
April 25, 2024 updated by: Maria I. Lapid, M.D., Mayo Clinic
A Feasibility Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) in Hospitalized Patients
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days.
Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory.
Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS.
A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS.
The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance.
Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah M Williams
- Phone Number: (507) 422-2972
- Email: Williams.Sarah2@mayo.edu
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- 18 years and older
- Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
- Hospitalized in psychiatric units
- Voluntary admission status
- Moderate or severe depression, defined by PHQ-9 ≥ 15
- Ability to provide informed consent
- Ability to adhere to protocol
Exclusion Criteria
- Bipolar disorder
- Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
- Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
- Contraindications to tDCS (including pacemaker, metallic implants in the head or neck [except orthodontic hardware], skin disease causing irritation)
- Current pregnancy or positive urine pregnancy test (clinical)
- Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tDCS interventional arm
Participants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days.
|
tDCS is a form of noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes.
The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A (Soterix Medical, Inc., New York, NY, USA) device will be used in the study.
The tDCS device is comprised of a small battery-operated control box that delivers the current through electrodes placed on the scalp, held in place by elastic bands or head straps and worn over the forehead like a headband.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility outcome
Time Frame: through study completion, an average of 2 weeks
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Defined as 70% of eligible patients choosing to enroll in the study.
Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection.
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through study completion, an average of 2 weeks
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Tolerability outcome
Time Frame: through study completion, an average of 2 weeks
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Defined as an overall tolerability rating of "very tolerable."
This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?"
The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable.
Other tolerability parameters will include the tDCS adverse effects questionnaire.
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through study completion, an average of 2 weeks
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Acceptability outcome
Time Frame: through study completion, an average of 2 weeks
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Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol.
Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments.
Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion.
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through study completion, an average of 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: baseline, 2 weeks
|
Measure of depressive symptoms.
Response is defined by a 50% or more reduction in MADRS score.
The MADRS has 10-items which are based on mood symptoms.
Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
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baseline, 2 weeks
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Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: baseline, 2 weeks
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Measure of anhedonia.
The SHAPS has 14-items which are based on pleasure symptoms.
Each item is scored 1 (definitely agree) to 4 (definitely disagree) with overall score ranges from 14 (experience high pleasure) to 56 (experience low pleasure)
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baseline, 2 weeks
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Change in Stroop Test
Time Frame: baseline, 2 weeks
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Measure of measure memory and executive function.
Reaction time (in seconds) in the different conditions of the task (reading the non-conflicting condition, reading the conflicting condition)
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baseline, 2 weeks
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Change in Revised Hopkins Verbal Learning Test (HVLT-R)
Time Frame: baseline, 2 weeks
|
Measure of verbal learning and memory.
The HVLT-R has 12-items which are based on memory score.
Total recall score (range from 0 to 36).
The higher the score indicates better short-term memory, lowers scores indicates worse short-term memory.
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baseline, 2 weeks
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Change in Digital Symbol Coding Test (DSCT)
Time Frame: baseline, 2 weeks
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Measure of working memory.
The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy to draw symbol.
Below the key are a series of numbers that 1-9 in random order and repeated several times, that are to be filled in the corresponding symbol for each number.
One point is given for each correct response.
Total scores range from 0-9, lower scores indicate worse memory; higher scores indicate better memory.
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baseline, 2 weeks
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Change in Peak alpha frequency (PAF)
Time Frame: baseline, 2 weeks
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EEG measure of the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance.
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baseline, 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria I Lapid, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
January 24, 2024
First Posted (Actual)
February 1, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-003274
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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