DepressionNCT06110715
Quantifying tACS-driven Improvement of Working Memory in Depression
A study testing theta tACS stimulation in people with Depression, run by University of Minnesota.
Trial summary
TACS is an emergent method of non-invasive neuromodulation which can engage frequency-specific brain oscillations. It is increasingly recognized that neural oscillations play a system-organizing role in the brain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- theta tACS stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2023to 16 Aug 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years old.
- Stated willingness to participate and comply with all study procedures.
- Stated availability for the duration of the study.
- Meet criteria for Major Depressive Disorder.
- Agreement to adhere to lifestyle considerations throughout study duration.
- No conflict of interest with the Department of Biomedical Engineering at the University of Minnesota.
- Confident level of English language.
Who cannot join
- History or evidence of chronic neurological disorder (e.g., history of seizures, epilepsy, unexplained episodes of loss of consciousness, serious brain injury, severe or frequent headaches)
- Metal or electric implant in the head, neck or chest area.
- Implanted pacemakers or other electrically, magnetically, ir mechanically activated implant
- Vascular clips or other electrically sensitive support systems in the brain
- Serious health conditions (e.g., congestive heart failure pulmonary obstructive chronic disease, active neoplasia)
- History of head injuries.
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- Pregnancy or breast-feeding.
- Significant damage of skin at sites of stimulation or other skin concerns, such as dermatitis, psoriasis, or eczema
- Alcohol or drug addiction.
- Any legal reason why the candidate cannot participate.
- Concurrent enrollment in another scientific or clinical study.
- Estimated IQ is below 70, defined by the WTAR.
- Active suicidality or other non-controlled neuropsychiatric illness. Active suicidality will be excluded based on a C-SSRS score of 3 or above in the last 6 months. Severe depression is defined as a PHQ-9 score above 20, which will also be excluded.
- A lifetime suicide attempt.
About this study
TACS is an emergent method of non-invasive neuromodulation which can engage frequency-specific brain oscillations. It is increasingly recognized that neural oscillations play a system-organizing role in the brain. Evidence suggests that disorganized neural oscillations may also influence functionality of cognitive processes such as working memory. Thus, as TACS can affect neural oscillatory activity in the human brain in a non-invasive manner, it has promise to transform mental health care. The premise of this proposed work is that tACS concurrent with multi-session working memory (WM) focused skills will facilitate durable working memory and stabilized neural oscillations. Depression offers an excellent model to study the effects of tACS. The study seeka to administer 2mA of tACS using theta oscillations to improve working memory concerns associated with depression. The purpose of this study is to investigate the electrophysiological and behavioral effects of transcranial alternating current stimulation (tACS) in humans and to explore specific improvements in working memory and depressive symptoms. This study is placebo-controlled study. Participants will undergo pre- and post-assessments and either theta or sham tACS for 5 days. During each session, the volunteer will perform cognitive tasks while receiving tACS. Assessment sessions will include cognitive tasks, questionnaires, a clinical interview, and EEG.
- Conditions
- Depression
- Being tested
- theta tACS stimulation, sham tACS stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theta tACS stimulationOther
The low intensity transcranial electrical stimulation will be administered with a battery-powered, current-controlled, multi-channel stimulator from Neuroelectrics® Starstim 8. This device comes with a neoprene headcap to hold the electrodes in place. TACS will be delivered concurrently with the task. The multichannel, current-driven stimulator (Neuroelectrics StarStim 8) will be used to control independent stimulation electrodes on the scalp of the volunteer. The stimulation intensity will be up to 2 mA.
sham tACS stimulationOther
A placebo control stimulation will use an identical montage to the stimulation montage. However, polarities of the electrodes will be such that only a minimal amount of current reaches the brain, which is achieved through controlled current shunting between neighboring electrodes. This so-called ActiSham protocol is a verified method to imitate the sensations of actual tACS, with minimal stimulation of the brain .
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | participants with depressive disorder Receives: Other: sham tACS stimulation |
| Active group | Experimental | participants with depressive disorder Receives: Other: theta tACS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
working memory skills
Using a cognitive task that will consist of test responses (correct / incorrect) and reaction time (in ms). The task will include looking at faces expressing different emotions and matching them with previous images.
Measured: Day 5
Resting state EEG
examine theta power and connectivity with the EEG recordings
Measured: Day 6
Resting state EEG
examine theta power and connectivity with the EEG recordings
Measured: Day 35
task-based EEG
examine theta power and connectivity with the EEG recordings
Measured: Day 6
task-based EEG
examine theta power and connectivity with the EEG recordings
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start5 Sep 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Why it stopped: no participants enrolled
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Opitz, PhD, Principal investigator, University of MinnesotaKelvin Lim, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110715
- Sponsor's protocol ID
- PSYCH-2023-31635
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2023
- Last updated
- 23 Sep 2024
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying tACS-driven Improvement of Working Memory in Depression
- ClinicalTrials.gov ID
- NCT06110715
- Acronym / sponsor ID
- PSYCH-2023-31635
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 1 Nov 2023 (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.
TACS is an emergent method of non-invasive neuromodulation which can engage frequency-specific brain oscillations. It is increasingly recognized that neural oscillations play a system-organizing role in the brain. Evidence suggests that disorganized neural oscillations may also influence functionality of cognitive processes such as working memory. Thus, as TACS can affect neural oscillatory activity in the human brain in a non-invasive manner, it has promise to transform mental health care. The premise of this proposed work is that tACS concurrent with multi-session working memory (WM) focused skills will facilitate durable working memory and stabilized neural oscillations. Depression offers an excellent model to study the effects of tACS. The study seeka to administer 2mA of tACS using theta oscillations to improve working memory concerns associated with depression. The purpose of this study is to investigate the electrophysiological and behavioral effects of transcranial alternating current stimulation (tACS) in humans and to explore specific improvements in working memory and depressive symptoms. This study is placebo-controlled study. Participants will undergo pre- and post-assessments and either theta or sham tACS for 5 days. During each session, the volunteer will perform cognitive tasks while receiving tACS. Assessment sessions will include cognitive tasks, questionnaires, a clinical interview, and EEG.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: sham tACS stimulationparticipants with depressive disorder |
| Active group | Experimental | Other: theta tACS stimulationparticipants with depressive disorder |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 60 years old.
- Stated willingness to participate and comply with all study procedures.
- Stated availability for the duration of the study.
- Meet criteria for Major Depressive Disorder.
- Agreement to adhere to lifestyle considerations throughout study duration.
Key exclusion criteria (14 listed)
- History or evidence of chronic neurological disorder (e.g., history of seizures, epilepsy, unexplained episodes of loss of consciousness, serious brain injury, severe or frequent headaches)
- Metal or electric implant in the head, neck or chest area.
- Implanted pacemakers or other electrically, magnetically, ir mechanically activated implant
- Vascular clips or other electrically sensitive support systems in the brain
- Serious health conditions (e.g., congestive heart failure pulmonary obstructive chronic disease, active neoplasia)
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 |
|---|---|---|
| theta tACS stimulationThe low intensity transcranial electrical stimulation will be administered with a battery-powered, current-controlled, multi-channel stimulator from Neuroelectrics® Starstim 8. This device comes with a neoprene headcap to hold the electrodes in place. TACS will be delivered concurrently with the task. The multichannel, current-driven stimulator (Neuroelectrics StarStim 8) will be used to control independent stimulation electrodes on the scalp of the volunteer. The stimulation intensity will be up to 2 mA. | Other | Active group |
| sham tACS stimulationA placebo control stimulation will use an identical montage to the stimulation montage. However, polarities of the electrodes will be such that only a minimal amount of current reaches the brain, which is achieved through controlled current shunting between neighboring electrodes. This so-called ActiSham protocol is a verified method to imitate the sensations of actual tACS, with minimal stimulation of the brain . | Other | control group |
Primary outcome
working memory skills
Time frame: Day 5
Using a cognitive task that will consist of test responses (correct / incorrect) and reaction time (in ms). The task will include looking at faces expressing different emotions and matching them with previous images.
Resting state EEG
Time frame: Day 6
examine theta power and connectivity with the EEG recordings
Resting state EEG
Time frame: Day 35
examine theta power and connectivity with the EEG recordings
task-based EEG
Time frame: Day 6
examine theta power and connectivity with the EEG recordings
task-based EEG
Time frame: Day 35
examine theta power and connectivity with the EEG recordings
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 23 Sep 2024.
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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.
Alexander Opitz, PhD principal investigator
University of Minnesota
Kelvin Lim, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing theta tACS stimulation in people with Depression, run by University of Minnesota.
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 7 inclusion and 14 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 23 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
working memory skills (time frame: Day 5). The study lists 5 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 23 Sep 2024.