DepressionSSDENCT03449979
Single Session of tACS in a Depressive Episode
A study testing XCSITE100 Stimulator tACS in people with Depression and Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders. Participants: 40 males and females, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Major Depressive Disorder, Premenstrual Dysphoric Disorder
- What is being tested?
- XCSITE100 Stimulator tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2018to 16 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-65 years
- Hamilton Depression Rating Scale score >8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Low suicide risk which will be determined through the use of both the Structured Clinical Interview for the DSM-5 and by scoring less than 3 (0,1, or 2) in the Hamilton rating depression scale.
- Negative pregnancy test for female participants
- Ages 18-65 years
Show all 9Show fewer
- Hamilton Depression Rating Scale score ≤8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Negative pregnancy test for female participants
Who cannot join
- DSM-5 diagnosis of alcohol of substance abuse (other than nicotine) within the 12 months
- DSM-5 diagnosis of alcohol or substance dependence (other than nicotine) within the last 12 months
- DSM-5 diagnosis of personality disorder
- Eating disorder (current or within the past 3 months)
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
- Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electro-convulsive therapy (ECT) induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurysm.
Show all 30Show fewer
- Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
- History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation or causing cognitive sequelae
- History of childhood trauma (determined by the Childhood Trauma Questionnaire)
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips
- Co-morbid neurological condition (i.e. seizure disorder, brain tumor)
- Use of illicit drugs, confirmed by a drug test
- Non English speakers
- Pregnant or nursing females
- Current use of benzodiazepines or anti-epileptic drugs
- History of major neurological or psychiatric illness, including epilepsy
- Medication use associated with neurological or psychiatric illnesses
- Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
- DSM-5 diagnosis of personality disorder
- First degree relative (parent, sibling, child) with major neurological or psychiatric illness
- Prior brain surgery
- Major head injury
- Any brain devices/implants (including cochlear implants and aneurysm clips)
- History of childhood trauma (determined by the Childhood Trauma Questionnaire)
- Use of illicit drugs, confirmed by a drug test
- Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
- Skin allergies or very sensitive skin
- Non English speakers
- Pregnant or nursing females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 3)
Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders.
Participants: 40 males and females, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric conditions.
Procedures: This is a single visit study with two stimulation conditions (tACS and sham tACS). The session will begin with clinical assessments (including confirmation of diagnosis), followed by an interactive EEG task, then a 7 minute resting state EEG (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes of tACS or sham tACS), followed by an additional 5 minute resting state EEG. The stimulation will involved 40 minutes of transcranial alternating current stimulation, 2 mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz).
Read the detailed description
Participants will report for a study visit and will review and sign a consent form.
Participants will complete several clinical assessments and also take a urine drug test and urine pregnancy test (if applicable). Eligibility will be re-assessed by the investigators before the participant moves on to the next phase.
If the participant still qualifies, the participant will first be fitted with two 5x5cm electrodes placed over F3/F4 (10-20 measurement system) and one 5x7cm electrode placed over Cz. In addition, the participant will have a 128-channel EEG net placed on their head. Participants will provide a saliva sample to assess for brain-derived neurotrophic factor (BDNF), which may affect how the participant's brain responds to stimulation. Once the participant is fitted with this equipment, the participant will complete two interactive EEG tasks, then 2-minute resting state EEG with the participant's eyes closed, then a 5-minute resting state EEG with the participant's eyes open.
Following these recordings, participants will respond to additional questionnaires. Immediately following this, the participant will receive 40 minutes of stimulation (tACS or sham tACS). During this stimulation, participants will sit comfortably upright and awake.
After stimulation has completed, participants will respond to additional questionnaires. Once completed, participants will then complete an additional 5-minute resting state EEG with the participant's eyes open, as well as complete one of the additional interactive EEG tasks.
Finally, participants will respond to a blinding questionnaire to assess if the participant thought that the participant received stimulation. Once complete, the participant will leave. This session is estimated to last about 4 hours.
- Conditions
- Depression, Major Depressive Disorder, Premenstrual Dysphoric Disorder, Depressive Episode
- Being tested
- XCSITE100 Stimulator Sham, XCSITE100 Stimulator tACS
- Keywords
- tACS, transcranial alternating current stimulation, stimulation, heart rate variability, electroencephalogram, EEG
- Medical subject headings
- Depression, Depressive Disorder, Major, Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCSITE100 Stimulator ShamDevice
Also called Sham tACS
The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
XCSITE100 Stimulator tACSDevice
Also called tACS
Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
| Study group | Role | What they receive |
|---|---|---|
| alpha stimulation in participants in a depressive episode | Experimental | Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Receives: Device: XCSITE100 Stimulator tACS |
| sham stimulation in participants in a depressive episode | Placebo comparator | Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham. Receives: Device: XCSITE100 Stimulator Sham |
| alpha stimulation in healthy participants | Experimental | Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. Receives: Device: XCSITE100 Stimulator tACS |
| sham stimulation in healthy participants | Placebo comparator | Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham. Receives: Device: XCSITE100 Stimulator Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation
Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
Measured: 5 minute recording before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start19 Sep 2018
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study recruits both participants currently experiencing a depressive episode (regardless of diagnosis) and those with no history of neurological or psychiatric illness. Randomization will occur in a 1:1 ratio for both of these groups, with half of each group receiving transcranial alternating current stimulation (tACS) at 10 Hz and the other half receiving placebo (or sham) stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449979
- Sponsor's protocol ID
- 16-1911b
- Other IDs
- R01MH101547
- Acronym
- SSDE
- Status last verified
- Sep 2019
- First submitted
- 15 Feb 2018
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 3)
- ClinicalTrials.gov ID
- NCT03449979
- Acronym / sponsor ID
- SSDE / 16-1911b
- Conditions
- Depression, Major Depressive Disorder, Premenstrual Dysphoric Disorder, Depressive Episode
- Keywords
- tACS, transcranial alternating current stimulation, stimulation, heart rate variability, electroencephalogram, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders.
Participants: 40 males and females, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric conditions.
Procedures: This is a single visit study with two stimulation conditions (tACS and sham tACS). The session will begin with clinical assessments (including confirmation of diagnosis), followed by an interactive EEG task, then a 7 minute resting state EEG (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes of tACS or sham tACS), followed by an additional 5 minute resting state EEG. The stimulation will involved 40 minutes of transcranial alternating current stimulation, 2 mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz).
Detailed description
Participants will report for a study visit and will review and sign a consent form.
Participants will complete several clinical assessments and also take a urine drug test and urine pregnancy test (if applicable). Eligibility will be re-assessed by the investigators before the participant moves on to the next phase.
If the participant still qualifies, the participant will first be fitted with two 5x5cm electrodes placed over F3/F4 (10-20 measurement system) and one 5x7cm electrode placed over Cz. In addition, the participant will have a 128-channel EEG net placed on their head. Participants will provide a saliva sample to assess for brain-derived neurotrophic factor (BDNF), which may affect how the participant's brain responds to stimulation. Once the participant is fitted with this equipment, the participant will complete two interactive EEG tasks, then 2-minute resting state EEG with the participant's eyes closed, then a 5-minute resting state EEG with the participant's eyes open.
Following these recordings, participants will respond to additional questionnaires. Immediately following this, the participant will receive 40 minutes of stimulation (tACS or sham tACS). During this stimulation, participants will sit comfortably upright and awake.
After stimulation has completed, participants will respond to additional questionnaires. Once completed, participants will then complete an additional 5-minute resting state EEG with the participant's eyes open, as well as complete one of the additional interactive EEG tasks.
Finally, participants will respond to a blinding questionnaire to assess if the participant thought that the participant received stimulation. Once complete, the participant will leave. This session is estimated to last about 4 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This study recruits both participants currently experiencing a depressive episode (regardless of diagnosis) and those with no history of neurological or psychiatric illness. Randomization will occur in a 1:1 ratio for both of these groups, with half of each group receiving transcranial alternating current stimulation (tACS) at 10 Hz and the other half receiving placebo (or sham) stimulation.
| Arm | Type | Receives |
|---|---|---|
| alpha stimulation in participants in a depressive episode | Experimental | Device: XCSITE100 Stimulator tACSParticipants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. |
| sham stimulation in participants in a depressive episode | Placebo comparator | Device: XCSITE100 Stimulator ShamSham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham. |
| alpha stimulation in healthy participants | Experimental | Device: XCSITE100 Stimulator tACSHealthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS. |
| sham stimulation in healthy participants | Placebo comparator | Device: XCSITE100 Stimulator ShamSham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18-65 years
- Hamilton Depression Rating Scale score >8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Low suicide risk which will be determined through the use of both the Structured Clinical Interview for the DSM-5 and by scoring less than 3 (0,1, or 2) in the Hamilton rating depression scale.
- Negative pregnancy test for female participants
Key exclusion criteria (30 listed)
- DSM-5 diagnosis of alcohol of substance abuse (other than nicotine) within the 12 months
- DSM-5 diagnosis of alcohol or substance dependence (other than nicotine) within the last 12 months
- DSM-5 diagnosis of personality disorder
- Eating disorder (current or within the past 3 months)
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
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 |
|---|---|---|
| XCSITE100 Stimulator ShamAlso: Sham tACSThe participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session. | Device | sham stimulation in healthy participants, sham stimulation in participants in a depressive episode |
| XCSITE100 Stimulator tACSAlso: tACSTranscranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied. | Device | alpha stimulation in healthy participants, alpha stimulation in participants in a depressive episode |
Primary outcome
Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation
Time frame: 5 minute recording before and after intervention
Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Flavio Frohlich, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XCSITE100 Stimulator tACS in people with Depression and Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 9 inclusion and 30 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: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation (time frame: 5 minute recording before and after intervention). 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 4 Jun 2020.