Trial Outcomes & Findings for Efficacy of CES in New Mothers During the Post Partum Period (NCT NCT03210155)
NCT ID: NCT03210155
Last Updated: 2020-08-17
Results Overview
Hamilton Anxiety Rating Scale (HAM-A14): The HAM-A probes 14 parameters. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe and combined to compute a total score. Higher total scores suggest worse outcomes Total score: 14-17 = Mild Anxiety Total score: 18-24 = Moderate Anxiety Total score: 25-30 = Severe Anxiety
TERMINATED
NA
1 participants
T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)
2020-08-17
Participant Flow
The only subject was recruited from study flyer in May 2018. Subject met inclusion criteria, provided informed consent and was recruited into the study.
The only subject recruited from study flyer in May 2018. Subject met inclusion criteria, provided informed consent and was recruited into the study.
Participant milestones
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
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|---|---|---|
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Overall Study
STARTED
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0
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1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
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0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of CES in New Mothers During the Post Partum Period
Baseline characteristics by cohort
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
n=1 Participants
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
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Total
n=1 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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—
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0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of participants ≥ 10.5 months postpartum
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—
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0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Delivery criteria
|
—
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1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of subjects who received contraception
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of Participants with No Current Abuse of Alchohol or Other Substance
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Capable of giving informed consent
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Ability to completing study requirements
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Screening instrument criteria
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)Population: No subjects were randomly assigned to an active comparator
Hamilton Anxiety Rating Scale (HAM-A14): The HAM-A probes 14 parameters. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe and combined to compute a total score. Higher total scores suggest worse outcomes Total score: 14-17 = Mild Anxiety Total score: 18-24 = Moderate Anxiety Total score: 25-30 = Severe Anxiety
Outcome measures
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
n=1 Participants
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
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|---|---|---|
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Hamilton Anxiety Rating Scale Scores Over Time
T3
|
—
|
14 score on a scale
|
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Hamilton Anxiety Rating Scale Scores Over Time
T1
|
—
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15 score on a scale
|
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Hamilton Anxiety Rating Scale Scores Over Time
T2
|
—
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15 score on a scale
|
SECONDARY outcome
Timeframe: T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)Population: No subjects were randomly assigned to an active comparator
Hamilton Depression Rating Scale17 (HAM-D17) Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe and combined to compute a total score. Nine items are scored from 0-2. Higher total scores suggest worse outcomes. Total score: 0-7 = Normal Total score: 8-13 = Mild Depression Total score: 14-18 = Moderate Depression Total score: 19-22 = Severe Depression Total score: ≥ 23 = Very Severe Depression 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression ≥ 23 = Very Severe Depression Higher total scores suggests worse outcomes
Outcome measures
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
n=1 Participants
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
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|---|---|---|
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Hamilton Depression Rating Scale Scores Over Time
T3
|
—
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8 score on a scale
|
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Hamilton Depression Rating Scale Scores Over Time
T1
|
—
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7 score on a scale
|
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Hamilton Depression Rating Scale Scores Over Time
T2
|
—
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7 score on a scale
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SECONDARY outcome
Timeframe: T1 (Baseline); T2 (3 weeks); T3 (6 weeks)Population: No subjects were randomly assigned to an active comparator
Pittsburg Sleep Quality Index (PSQI19) A 19-item scale that measures sleep quality during the previous month and discriminates between good and poor sleepers The PSQI19 is a 19-item scale that measures sleep quality during the previous month and discriminates between good and poor sleepers 0 = no difficulty 3 = indicates severe difficulty Seven component scores are then added to yield one "global" score, with a range of 0 = 21 points 0 = indicating no difficulty to 21 = indicating severe difficulties in all areas.
Outcome measures
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
n=1 Participants
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index Scale Scores Over Time
T1
|
—
|
8 score on a scale
|
|
Pittsburgh Sleep Quality Index Scale Scores Over Time
T3
|
—
|
6 score on a scale
|
|
Pittsburgh Sleep Quality Index Scale Scores Over Time
T2
|
—
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7 score on a scale
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SECONDARY outcome
Timeframe: T1 (baseline); T2 (3 weeks); T3 (6 weeks)Population: No subjects were randomly assigned to an active comparator
The Insomnia Severity Index (ISI7) Items include: the severity of sleep onset and maintenance (middle and early morning awakening) difficulties, satisfaction with current sleep pattern, interference with daily functioning, appearance of impairment attributed to the sleep problem, and the degree of concern caused by insomnia Total score categories: 0 - 7 = No clinically significant insomnia 8 - 14 = Sub threshold insomnia 15 - 21 = Clinical insomnia (moderate severity) 22 - 28 = Clinical insomnia (severe) Higher scores indicate worse outcomes
Outcome measures
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
n=1 Participants
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
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|---|---|---|
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Insomnia Severity Index Scores Over Time
T1
|
—
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1 score on a scale
|
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Insomnia Severity Index Scores Over Time
T2
|
—
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2 score on a scale
|
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Insomnia Severity Index Scores Over Time
T3
|
—
|
5 score on a scale
|
SECONDARY outcome
Timeframe: T1 (baseline); T2 (3 weeks); T3 (6 weeks)Population: No subjects were randomly assigned to an active comparator
Barkin Index of Maternal Functioning (BIMF20) The Barkin Index of Maternal Functioning (BIMF) is a 20-item self-report measure that was designed to assess overall functioning in the context of new motherhood. After reverse-coding for items 16 and 18, the BIMF is scored by simply summing all 20 items. Total score ranges from 0 to 120 Higher scores represent better outcomes
Outcome measures
| Measure |
Active Comparator
About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Active Comparator): The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
|
Sham Comparator
n=1 Participants
The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
Alpha-Stim AID CES (Sham Comparator): The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
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|---|---|---|
|
Barkin Index of Maternal Functioning Scores Over Time
T1
|
—
|
93 score on a scale
|
|
Barkin Index of Maternal Functioning Scores Over Time
T2
|
—
|
97 score on a scale
|
|
Barkin Index of Maternal Functioning Scores Over Time
T3
|
—
|
92 score on a scale
|
Adverse Events
Active Comparator
Sham Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christina Murphey
Texas A&M University Corpus Christi
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place