Trial Outcomes & Findings for Effectiveness of CES on Emotional and Cellular Wellbeing (NCT NCT03369418)
NCT ID: NCT03369418
Last Updated: 2020-08-19
Results Overview
The Hospital anxiety and depression scale (HADS) evaluates symptoms of anxiety and depression, minimum 0 and maximum 52 with higher scores indicating more symptoms. A combined score it utilized as the primary outcome measure, summing the scores for anxiety and depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
After completion of the study (1 year)
Results posted on
2020-08-19
Participant Flow
Subjects were recruited by flyers from the WLA VA Integrative Medicine Clinics and on the UCLA campus between April 2016 and August 2018.
Participant milestones
| Measure |
Active
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
|
Inactive
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Active
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
|
Inactive
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Effectiveness of CES on Emotional and Cellular Wellbeing
Baseline characteristics by cohort
| Measure |
Active
n=13 Participants
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
|
Inactive
n=11 Participants
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.62 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
27.09 years
STANDARD_DEVIATION 5.72 • n=7 Participants
|
27.92 years
STANDARD_DEVIATION 6.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After completion of the study (1 year)The Hospital anxiety and depression scale (HADS) evaluates symptoms of anxiety and depression, minimum 0 and maximum 52 with higher scores indicating more symptoms. A combined score it utilized as the primary outcome measure, summing the scores for anxiety and depression.
Outcome measures
| Measure |
Active
n=13 Participants
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
|
Inactive
n=11 Participants
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
|
|---|---|---|
|
HADS Questionnaire Combined Score
Baseline estimated means
|
20.3077 score on a scale
Standard Error 1.65
|
19.909 score on a scale
Standard Error 1.79
|
|
HADS Questionnaire Combined Score
Post treatment estimated mean
|
11.1538 score on a scale
Standard Error 1.65
|
15.4545 score on a scale
Standard Error 1.79
|
SECONDARY outcome
Timeframe: After completion of the study (1 year)Population: 2 subjects had inadequate samples for analysis of telomere length, both in the active arm.
Telomere length will be determined using real time quantitative polymerase chain reaction (qPCR) methodology as described previously with minor modifications.30,31 Peripheral blood mononuclear cells (PBMC) are isolated and genomic DNA extracted. Using the standard curve method, cycle threshold (CT) values are plotted on a standard curve of human genomic DNA to estimate an ng/microliter concentration value. Telomere length values are expressed as the ratio of the estimated concentration generated by PCR of the telomere gene (T) divided by the hemoglobin single (S) copy gene = (T/S).
Outcome measures
| Measure |
Active
n=11 Participants
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
|
Inactive
n=11 Participants
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
|
|---|---|---|
|
Telomere Length
|
.6945 T/S
Standard Error .03231
|
.7841 T/S
Standard Error .03487
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Inactive
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=13 participants at risk
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Active: The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
|
Inactive
n=11 participants at risk
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Alpha-Stim Inactive: The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
|
|---|---|---|
|
General disorders
fatigue
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
0.00%
0/11 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
Ear and labyrinth disorders
ear infection
|
7.7%
1/13 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
0.00%
0/11 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
Psychiatric disorders
increased irritability
|
0.00%
0/13 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
0.00%
0/13 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
Endocrine disorders
vitamin d deficiency
|
0.00%
0/13 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
Nervous system disorders
headahce
|
0.00%
0/13 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
Psychiatric disorders
panic attack
|
0.00%
0/13 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
|
General disorders
insomnia
|
0.00%
0/13 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the study period (10 weeks).
The protocol and description of adverse events (AE) and Serious adverse events (SAE) is also detailed in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place