Depression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENexalin Based Trans-Cranial Electrical Stimulation
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.
Sponsors
Carrier Clinic
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants and investigators are blind to condition.
Intervention model description
A 2x2 factor Randomized Controlled Trial with block randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. In-patients at the Carrier Clinic 2. Adults over age 18 and under age 65 3. Able to speak, read and write fluently in English, assessed by the study coordinator at Carrier Clinic 4. Screened Negative for alcohol abuse and/or dependence 5. Able to provide informed consent, assessed by the study coordinator at Carrier Clinic 6. Referred for ECT 7. Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial 8. Not pregnant or intending to become pregnant during the study 9. Committed to completion of the study
Exclusion criteria
Medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response | 1-2 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Electrical Stimulation Transcranial Electrical Stimulation (TES). Active Treatment. | 50 |
| SHAM -TES Sham/placebo condition | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inpatient stay too brief | 12 | 11 |
Baseline characteristics
| Characteristic | Transcranial Electrical Stimulation | SHAM -TES | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 51 Participants | 101 Participants |
| Age, Continuous | 32.6 years STANDARD_DEVIATION 2.4 | 35.9 years STANDARD_DEVIATION 2.3 | 34.2 years STANDARD_DEVIATION 2.35 |
| Race/Ethnicity, Customized African American | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 8 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 32 Participants | 67 Participants |
| Region of Enrollment United States | 50 participants | 51 participants | 101 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 30 Participants | 31 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 0 / 50 | 0 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
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.
Time frame: 1-2 weeks
Population: 101 were enrolled. 78 subjects were in study for the minimum time / minimum number of treatments and provided the full compliment of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcranial Electrical Stimulation | Treatment Response | 28 Participants |
| TES-SHAM | Treatment Response | 29 Participants |