Trial Outcomes & Findings for Transcranial Direct Current Stimulation Therapy for Major Depression (NCT NCT03632434)
NCT ID: NCT03632434
Last Updated: 2024-08-01
Results Overview
As measured by a Hamilton Depression Rating Scale score that is less than or equal to 50% of the baseline Hamilton Depression Rating Scale score. Higher scores indicate greater depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
At 6 weeks following course of tDCS treatment
Results posted on
2024-08-01
Participant Flow
Participant milestones
| Measure |
tDCS
6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.
transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
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|---|---|
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
tDCS
6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.
transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Transcranial Direct Current Stimulation Therapy for Major Depression
Baseline characteristics by cohort
| Measure |
tDCS
n=26 Participants
6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.
transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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24 Participants
n=5 Participants
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
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Age, Continuous
|
40.85 years
STANDARD_DEVIATION 14.16 • n=5 Participants
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Sex: Female, Male
Female
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19 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
White British
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16 Participants
n=5 Participants
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Race/Ethnicity, Customized
White and Black African
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
White and Asian
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Any other White Background
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Any other mixed/ Multiple ethnic background
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Pakistani
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Chinese
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Any other Black/African/Caribbean background
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3 Participants
n=5 Participants
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Region of Enrollment
United Kingdom
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26 Participants
n=5 Participants
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Hamilton Depression Rating Scale score
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19.12 units on a scale
STANDARD_DEVIATION 2.12 • n=5 Participants
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PRIMARY outcome
Timeframe: At 6 weeks following course of tDCS treatmentAs measured by a Hamilton Depression Rating Scale score that is less than or equal to 50% of the baseline Hamilton Depression Rating Scale score. Higher scores indicate greater depressive symptoms.
Outcome measures
| Measure |
tDCS
n=24 Participants
6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.
transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
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|---|---|
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Clinical Response
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22 Participants
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Adverse Events
tDCS
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tDCS
n=26 participants at risk
6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.
transcranial direct current stimulation: tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
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|---|---|
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General disorders
Headache
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84.6%
22/26 • Number of events 43 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Skin redness
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92.3%
24/26 • Number of events 104 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Itching
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65.4%
17/26 • Number of events 46 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Tingling
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84.6%
22/26 • Number of events 94 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Burning sensation
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69.2%
18/26 • Number of events 76 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Musculoskeletal and connective tissue disorders
Neck pain
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26.9%
7/26 • Number of events 8 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Skin and subcutaneous tissue disorders
Scalp pain
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30.8%
8/26 • Number of events 16 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Sleepiness
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69.2%
18/26 • Number of events 52 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Trouble concentrating
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53.8%
14/26 • Number of events 38 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Psychiatric disorders
Acute mood change
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30.8%
8/26 • Number of events 13 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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General disorders
Tingling in face
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3.8%
1/26 • Number of events 1 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Eye disorders
Blurry vision
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3.8%
1/26 • Number of events 2 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Respiratory, thoracic and mediastinal disorders
Altered breathing
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3.8%
1/26 • Number of events 1 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Skin and subcutaneous tissue disorders
Dry skin
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11.5%
3/26 • Number of events 4 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Psychiatric disorders
Increased anxiety
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3.8%
1/26 • Number of events 1 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Eye disorders
Flash of light in vision
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3.8%
1/26 • Number of events 1 • Participants were asked about adverse events by researchers before and after every tDCS session for 6 weeks, then at 3 and 6 month follow-up visits. A total time frame of 7.5 months.
In addition to asking participants about adverse events at every tDCS session and at follow up, the tDCS adverse events questionnaire was completed weekly during the 6-week treatment period to record adverse events that participants felt were related to the tDCS. Reported adverse events are for all participants across the full 6-weeks of treatment and indicate how many participants experienced the adverse event and how many times in total each adverse event was reported.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place