Trial Outcomes & Findings for Empower: tDCS for Major Depressive Disorder at Home (NCT NCT05202119)
NCT ID: NCT05202119
Last Updated: 2026-04-22
Results Overview
Comparison of mean score change based on HDRS-17 scores of the two arms at 10 weeks. Mean score change is calculated as change in score from baseline to week 10. HDRS-17 is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 52. Higher scores represent greater severity of depressive symptoms.
COMPLETED
NA
174 participants
10 weeks
2026-04-22
Participant Flow
Recruitment was from 12 May 2022 to 10 March 2023. Participants were recruited through the Flow Neuroscience website, email lists, and social media posts from throughout England and Wales (UK) and Texas (USA). From 17,951 individuals who completed an online pre-screen survey and 2,234 who had a pre-screen assessment via telephone, 368 individuals provided written informed consent and were assessed for eligibility via video conference.
368 participants signed a consent form and were assessed for eligibility. 194 participants were excluded at the eligibility screening phase. 174 participants who had signed the consent form were enrolled onto the trial and were randomized (87 active, 87 sham). One participant in the sham group did not receive any treatment and was excluded from the modified intention-to-treat analysis (n=173).
Participant milestones
| Measure |
Active Stimulation
Active stimulation at 2mA
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
|
Sham Stimulation
Sham Transcranial direct current stimulation: To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
|
|---|---|---|
|
Blinded Phase (week 0 - week 10)
STARTED
|
87
|
87
|
|
Blinded Phase (week 0 - week 10)
Started treatment with intervention - included in modified intention to treat analysis
|
87
|
86
|
|
Blinded Phase (week 0 - week 10)
COMPLETED
|
74
|
75
|
|
Blinded Phase (week 0 - week 10)
NOT COMPLETED
|
13
|
12
|
|
Open Label Phase - Week 10 - Week 20)
STARTED
|
67
|
71
|
|
Open Label Phase - Week 10 - Week 20)
COMPLETED
|
55
|
56
|
|
Open Label Phase - Week 10 - Week 20)
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Active Stimulation
Active stimulation at 2mA
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
|
Sham Stimulation
Sham Transcranial direct current stimulation: To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
|
|---|---|---|
|
Blinded Phase (week 0 - week 10)
Withdrawal by Subject
|
2
|
4
|
|
Blinded Phase (week 0 - week 10)
Protocol Violation
|
6
|
5
|
|
Blinded Phase (week 0 - week 10)
Lost to Follow-up
|
2
|
2
|
|
Blinded Phase (week 0 - week 10)
Pregnancy
|
0
|
1
|
|
Blinded Phase (week 0 - week 10)
Did not complete 60% or more sessions
|
3
|
0
|
Baseline Characteristics
Empower: tDCS for Major Depressive Disorder at Home
Baseline characteristics by cohort
| Measure |
Active Stimulation
n=87 Participants
Active stimulation at 2mA
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
|
Sham Stimulation
n=87 Participants
Sham Transcranial direct current stimulation: To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=60 Participants
|
87 Participants
n=56 Participants
|
174 Participants
n=116 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Age, Continuous
|
37.09 years
STANDARD_DEVIATION 11.14 • n=60 Participants
|
38.32 years
STANDARD_DEVIATION 10.92 • n=56 Participants
|
37.63 years
STANDARD_DEVIATION 11.00 • n=116 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=60 Participants
|
66 Participants
n=56 Participants
|
120 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=60 Participants
|
21 Participants
n=56 Participants
|
54 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
11 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=60 Participants
|
73 Participants
n=56 Participants
|
145 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=60 Participants
|
11 Participants
n=56 Participants
|
14 Participants
n=116 Participants
|
|
HDRS-17 - Hamilton Depression Rating Scale
|
19.18 Total score
STANDARD_DEVIATION 2.83 • n=60 Participants
|
18.92 Total score
STANDARD_DEVIATION 2.63 • n=56 Participants
|
19.05 Total score
STANDARD_DEVIATION 2.74 • n=116 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Modified intention-to-treat analysis: all randomized participants who received at least one tDCS session. One participant in the sham group was excluded for not receiving any treatment.
Comparison of mean score change based on HDRS-17 scores of the two arms at 10 weeks. Mean score change is calculated as change in score from baseline to week 10. HDRS-17 is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 52. Higher scores represent greater severity of depressive symptoms.
Outcome measures
| Measure |
Active Stimulation
n=87 Participants
Active stimulation at 2mA
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
|
Sham Stimulation
n=86 Participants
Sham Transcranial direct current stimulation: To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
|
|---|---|---|
|
HDRS-17 - Hamilton Depression Ratin Scale
|
9.41 score on a scale
Standard Deviation 6.25
|
7.14 score on a scale
Standard Deviation 6.1
|
Adverse Events
Active Stimulation
Sham Stimulation
Serious adverse events
| Measure |
Active Stimulation
n=87 participants at risk
Active stimulation at 2mA
Transcranial direct current stimulation: Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
|
Sham Stimulation
n=86 participants at risk
Sham Transcranial direct current stimulation: To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hospitalization for hypertension
|
1.1%
1/87 • From enrollment to 10 weeks
Unanticipated adverse events were collected throughout the study. Anticipated adverse events were assessed using the tDCS Adverse Events Questionnaire (AEQ) at week 10.
|
0.00%
0/86 • From enrollment to 10 weeks
Unanticipated adverse events were collected throughout the study. Anticipated adverse events were assessed using the tDCS Adverse Events Questionnaire (AEQ) at week 10.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place