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| Name | Class |
|---|---|
| Carrier Clinic | OTHER |
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The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical Stimulation (TES) is an effective treatment for depression among patients who are candidates for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT. Although Nexalin has been approved for use in the US, using Nexalin to treat depression in this way is investigational and experimental. If Nexalin is found to be an alternative to ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.
!!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs. rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the study was framed as a simple comparison between TES and SHAM TES.
A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment non-responders in either condition will continue as in patients at the Carrier Clinic until they reach acceptable levels of functioning to be discharged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accept ECT - TES | Experimental | Accept ECT where subject is randomized to TES |
|
| Accept ECT - SHAM | Placebo Comparator | Accept ECT where subject is randomized to a SHAM condition |
|
| Reject ECT - TES | Experimental | Reject ECT where subject is randomized to TES |
|
| Reject ECT - SHAM | Placebo Comparator | Reject ECT where subject is randomized to SHAM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexalin Based Trans-Cranial Electrical Stimulation | Device | The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response | Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents "not at all" and 3 represents "nearly every day". The scale ranges from 0-27. We used percent change (from admission to "ex-take") as a our metric. | 1-2 weeks |
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Inclusion Criteria:
Exclusion Criteria: Medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Perlis, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrier Clinic | Belle Mead | New Jersey | 08502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29207262 | Background | Bestmann S, Walsh V. Transcranial electrical stimulation. Curr Biol. 2017 Dec 4;27(23):R1258-R1262. doi: 10.1016/j.cub.2017.11.001. | |
| 28709880 | Background | Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19. |
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The de-identified data will be shared with our collaborators at Nexalin and Carrier Clinic.
with 6-18 months
Only our direct collaborators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Electrical Stimulation (Active) | All subjects get active treatment with Transcranial Electrical Stimulation |
| FG001 | TES SHAM | All subjects get SHAM treatment with TES |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Electrical Stimulation | Transcranial Electrical Stimulation (TES). Active Treatment. |
| BG001 | SHAM -TES | Sham/placebo condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Treatment Response | Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents "not at all" and 3 represents "nearly every day". The scale ranges from 0-27. We used percent change (from admission to "ex-take") as a our metric. | 101 were enrolled. 78 subjects were in study for the minimum time / minimum number of treatments and provided the full compliment of data. | Posted | Count of Participants | Participants | 1-2 weeks |
|
1 year
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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 | Transcranial Electrical Stimulation | TES = Transcranial Electrical Stimulation (active treatment) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Perlis | University of Pennsylvania | 215-746-3577 | mperlis@upenn.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 10, 2017 | Aug 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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A 2x2 factor Randomized Controlled Trial with block randomization
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All participants and investigators are blind to condition.
|
|
| 28688701 | Background | Yavari F, Jamil A, Mosayebi Samani M, Vidor LP, Nitsche MA. Basic and functional effects of transcranial Electrical Stimulation (tES)-An introduction. Neurosci Biobehav Rev. 2018 Feb;85:81-92. doi: 10.1016/j.neubiorev.2017.06.015. Epub 2017 Jul 6. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
SHAM treatment (no current). Otherwise procedures identical.
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | SHAM-TES | TES. No current. Procedures were otherwise identical between conditions | 0 | 51 | 0 | 51 | 0 | 51 |
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