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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH101547-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).
Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces cortical hyperactivity and causes a clinical improvement
Aim 1: To conduct a pilot clinical trial to establish feasibility and to collect first effectiveness data for the use of tACS to renormalize pathological alpha oscillations in the dorsolateral prefrontal cortex (dl-pfc) of unmedicated patients with MDD by comparing MADRS scores from baseline and one month follow up.
Aim 2: Compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. Collect EEG data at the one month follow up visit using this data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tACS (alpha) | Experimental | 10 Hz tACS with a peak-to-peak amplitude of 2 milliamps (mA) for 40 minutes. Uses tACS (alpha) device. |
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| tACS (gamma) | Experimental | 40 Hz tACS with a peak-to-peak amplitude of 2 milliamps (mA) for 40 minutes. Uses tACS (gamma) device. |
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| Sham stimulation | Sham Comparator | Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. Uses tACS (alpha) device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tACS (alpha) | Device |
| ||
| tACS (gamma) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms. | Baseline to F2 (4 weeks after completion of the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) Score | The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD | University of North Carolina at Chapel Hill, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill Medical School Wing C | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23625554 | Background | Valiengo L, Bensenor IM, Goulart AC, de Oliveira JF, Zanao TA, Boggio PS, Lotufo PA, Fregni F, Brunoni AR. The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases. Depress Anxiety. 2013 Jul;30(7):646-53. doi: 10.1002/da.22079. Epub 2013 Apr 26. |
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Participants were randomly assigned to 1 of 3 arms: tACS (alpha), tACS (gamma), or sham stimulation. All conditions were delivered during awake, resting state for 40 minutes on 5 consecutive days. 98 participants signed consent, 40 did not meet criteria, 6 declined participation, and 20 were excluded for other reasons. 32 were randomized.
Participants were recruited through advertisements (e.g., online, flyers) and self-identified with depression. Interested participants contacted the study team.
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| ID | Title | Description |
|---|---|---|
| FG000 | tACS (Alpha) | 10 Hz transcranial alternating current stimulation (tACS) with a peak-to-peak amplitude of 2 mA for 40 minutes |
| FG001 | tACS (Gamma) | 40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes |
| FG002 | Sham Stimulation | Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | tACS (Alpha) | 10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes |
| BG001 | tACS (Gamma) | 40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline to F2 (4 weeks after completion of the intervention) |
|
Throughout the intervention period and throughout F2 (4 weeks after completion of the intervention), for an average of 5 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tACS (Alpha) | 10 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Flavio Frohlich | University of North Carolina at Chapel Hill | (919) 966-4584 | flavio_frohlich@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2016 | Jun 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Device |
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| Baseline to Day 5 of Stimulation |
| Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions. | Baseline to F2 |
| Baseline to Day 5 of Stimulation; Baseline to F2 |
| Change in Montreal Cognitive Assessment (MoCA) Score | This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline. | Baseline to F2 |
| Change in Beck Depression Inventory (BDI) Score | This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms. | Baseline to Day 5; Baseline to F2 |
| Clinical Global Impressions (CGI) Raw Score | This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 "Severity of Illness" on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients. | Day 5; F2 (4 weeks after completion of treatment) |
| Protocol Deviation |
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| BG002 | Sham Stimulation | Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Depression Rating Scale (HDRS) | The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. Higher scores indicate more depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory (BDI) | The BDI is a self-administered questionnaire that measures the occurrence and severity of current depressive symptoms. Total scores range from 0-63 with higher scores indicating higher feelings of being depressed. | Mean | Standard Deviation | units on a scale |
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| Montreal Cognitive Assessment (MoCA) | A basic assessment of cognition. Total score is ranges from 0 to 30 points, with higher values indicating better cognition. | Mean | Standard Deviation | units on a scale |
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| Clinical Global Impression (CGI) | Values reported on Item 1 "Severity of Illness" on the Clinical Global Impressions scale. Patients are scored on a likert scale, with 1 = "Normal, not at all ill" to 7 = "Among the most extremely ill patients." | Mean | Standard Deviation | units on a scale |
|
| OG001 | tACS (Gamma) | 40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes |
| OG002 | Sham Stimulation | Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. |
|
|
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| Secondary | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation | The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions. | Only participants that completed all sessions are used in this task (per protocol participants); N = 26 | Posted | Mean | Standard Deviation | decibel (dB) | Baseline to Day 5 of Stimulation |
|
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| Secondary | Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention | The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions. | Only participants that completed all sessions are used in this task (per protocol participants); N = 26 | Posted | Mean | Standard Deviation | decibel (dB) | Baseline to F2 |
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| Other Pre-specified | Change in Hamilton Depression Rating Scale (HDRS) Score | The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 5 of Stimulation; Baseline to F2 |
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| Other Pre-specified | Change in Montreal Cognitive Assessment (MoCA) Score | This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline to F2 |
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| Other Pre-specified | Change in Beck Depression Inventory (BDI) Score | This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 5; Baseline to F2 |
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| Other Pre-specified | Clinical Global Impressions (CGI) Raw Score | This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 "Severity of Illness" on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients. | Posted | Mean | Standard Deviation | units on a scale | Day 5; F2 (4 weeks after completion of treatment) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | tACS (Gamma) | 40 Hz transcranial alternating current stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Sham Stimulation | Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups. Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups. | ANOVA | F(3, 79.358) | <0.001 | Other | F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal) |
| Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups. Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups. | ANOVA | F(6, 68.284) | >0.10 | Other | F-test; Interaction effect (region x condition) |
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