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Trial Outcomes & Findings for The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression (NCT NCT03277846)

NCT ID: NCT03277846

Last Updated: 2019-10-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

1-2 weeks

Results posted on

2019-10-28

Participant Flow

Participant milestones

Participant milestones
Measure
Transcranial Electrical Stimulation (Active)
All subjects get active treatment with Transcranial Electrical Stimulation
TES SHAM
All subjects get SHAM treatment with TES
Overall Study
STARTED
50
51
Overall Study
COMPLETED
38
40
Overall Study
NOT COMPLETED
12
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Transcranial Electrical Stimulation (Active)
All subjects get active treatment with Transcranial Electrical Stimulation
TES SHAM
All subjects get SHAM treatment with TES
Overall Study
Inpatient stay too brief
12
11

Baseline Characteristics

The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Transcranial Electrical Stimulation
n=50 Participants
Transcranial Electrical Stimulation (TES). Active Treatment.
SHAM -TES
n=51 Participants
Sham/placebo condition
Total
n=101 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
50 Participants
n=5 Participants
51 Participants
n=7 Participants
101 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
32.6 years
STANDARD_DEVIATION 2.4 • n=5 Participants
35.9 years
STANDARD_DEVIATION 2.3 • n=7 Participants
34.2 years
STANDARD_DEVIATION 2.35 • n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
20 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex: Female, Male
Male
30 Participants
n=5 Participants
31 Participants
n=7 Participants
61 Participants
n=5 Participants
Race/Ethnicity, Customized
White
35 Participants
n=5 Participants
32 Participants
n=7 Participants
67 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Native American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Multi-Racial
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Race/Ethnicity, Customized
Unknown
8 Participants
n=5 Participants
10 Participants
n=7 Participants
18 Participants
n=5 Participants
Region of Enrollment
United States
50 participants
n=5 Participants
51 participants
n=7 Participants
101 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Transcranial Electrical Stimulation
n=38 Participants
Transcranial Electrical Stimulation (Active Tx)
TES-SHAM
n=40 Participants
SHAM treatment (no current). Otherwise procedures identical.
Treatment Response
28 Participants
29 Participants

Adverse Events

Transcranial Electrical Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SHAM-TES

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Perlis

University of Pennsylvania

Phone: 215-746-3577

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place