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| Name | Class |
|---|---|
| Mending Minds Foundation | UNKNOWN |
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Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Active Comparator | The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. |
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| Sham stimulation | Placebo Comparator | Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisher Wallace Cranial Stimulator | Device | The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. |
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| Measure | Description | Time Frame |
|---|---|---|
| BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits | Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption. | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only | Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott E Lukas, PhD | McLean Imaging Center, McLean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15646771 | Background | Gilula MF, Barach PR. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. South Med J. 2004 Dec;97(12):1269-70. doi: 10.1097/01.SMJ.0000136304.33212.06. No abstract available. | |
| Background | Smith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active First, Then Sham | Active treatment first, then Sham Active: The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. Fisher Wallace Cranial Stimulator Sham: Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. |
| FG001 | Sham First, Then Active | Sham first, then Active treatment Active: The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. Fisher Wallace Cranial Stimulator Sham: Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Second Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All of the study participants |
| 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 | BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits | Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption. | Data were not collected | Posted | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
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Only one participant completed the Sham intervention.
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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 | Active Stimulation | The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA. Fisher Wallace Cranial Stimulator |
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Small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott E. Lukas, Ph.D. | McLean Imaging Center, McLean Hospital | 617-855-2767 | slukas@mclean.harvard.edu |
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| within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
| Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm | Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of "not at all" (10) to "most ever" (50) were used to rank each measure. Change compares post-treatment to pre-treatment. Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome. | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
| Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Visual Analogue Scale (VAS) ranges from 0-100. Anchors of "not at all" (0) to "most ever" (100) were used to rank the following: anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment. | within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
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| 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 | Number | participants |
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| Caffeine consumption | Mean | Standard Deviation | caffeinated beverages/week |
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| Alcohol consumption | Mean | Standard Deviation | alcoolic drinks/week |
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| Marihuana use (spelling with 'h' used by DEA and FDA) | Mean | Standard Deviation | lifetime uses |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| OG001 | Sham Stimulation | Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current. Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. |
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| Secondary | BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only | Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption. | Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only | Posted | Mean | Standard Deviation | coupling ratio | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
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| Secondary | Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm | Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of "not at all" (10) to "most ever" (50) were used to rank each measure. Change compares post-treatment to pre-treatment. Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome. | Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only. | Posted | Mean | Standard Deviation | units on a scale | within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
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| Secondary | Change in Visual Analogue Scale (VAS) in Active Stimulation Arm | Visual Analogue Scale (VAS) ranges from 0-100. Anchors of "not at all" (0) to "most ever" (100) were used to rank the following: anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment. | Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only. 3 participants were missing data on these measures. | Posted | Mean | Standard Deviation | units on a scale | within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment |
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Sham Stimulation | Participants are outfitted with a device that is identical in appearance but does not deliver any current. | 0 | 1 | 0 | 1 |
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| Title | Measurements |
|---|---|
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| Relaxed |
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| Physical symptoms |
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| Confused |
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| Sluggish |
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| Energetic |
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| Fatigued |
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| Stressed |
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