Trial Outcomes & Findings for Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders (NCT NCT06203717)
NCT ID: NCT06203717
Last Updated: 2025-11-05
Results Overview
Feasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
During four weeks of cranial electrotherapy stimulation at-home use
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
Baseline characteristics by cohort
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
n=13 Participants
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Age, Continuous
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37.15 years
STANDARD_DEVIATION 11.07 • n=15 Participants
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Sex: Female, Male
Female
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1 Participants
n=15 Participants
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Sex: Female, Male
Male
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12 Participants
n=15 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=15 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=15 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=15 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=15 Participants
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Race (NIH/OMB)
White
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13 Participants
n=15 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=15 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=15 Participants
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Region of Enrollment
United States
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13 participants
n=15 Participants
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Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5
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20 score on PTSD Checklist for DSM-5
n=15 Participants
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Inventory of Depressive Symptomatology-Self Report (IDS-SR).
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18.77 score on IDS-SR
STANDARD_DEVIATION 11.35 • n=15 Participants
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PRIMARY outcome
Timeframe: During four weeks of cranial electrotherapy stimulation at-home useFeasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed).
Outcome measures
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
n=13 Participants
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Feasibility of Cranial Electrotherapy Stimulation
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86.15 percentage of CES sessions completed
Standard Deviation 16.51
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PRIMARY outcome
Timeframe: During four weeks of cranial electrotherapy stimulationAcceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks
Outcome measures
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
n=13 Participants
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Acceptability of Cranial Electrotherapy Stimulation
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10 Participants
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SECONDARY outcome
Timeframe: Post four weeks of cranial electrotherapy stimulationScore on the PTSD Checklist for DSM-5 (PCL-5). Scale ranges from 0 to 80 with higher scores indicating greater severity of posttraumatic stress disorder symptoms.
Outcome measures
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
n=13 Participants
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5)
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10.85 score on PTSD Checklist for DSM-5
Standard Deviation 10.54
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SECONDARY outcome
Timeframe: post four weeks of cranial electrotherapy stimulation.Score on the Inventory of Depressive Symptomatology-Self Report (IDS-SR). The Inventory of Depressive Symptomatology-Self Report (IDS-SR) has a total score range of 0 to 84, with each of its 30 items rated on a scale from 0 to 3. Scores of 18 or above on the IDS-SR indicate the presence of clinically relevant depressive symptomatology.
Outcome measures
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
n=13 Participants
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR)
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11.00 score on Inventory of Depressive Symptom
Standard Deviation 7.54
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SECONDARY outcome
Timeframe: Daily throughout four weeks of cranial electrotherapy stimulationIntensity of subjective fatigue assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily throughout four weeks of cranial electrotherapy stimulationIntensity of anxiety will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Outcome measures
Outcome data not reported
Adverse Events
Alpha-Stim AID cranial electrotherapy stimulation
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alpha-Stim AID cranial electrotherapy stimulation
n=13 participants at risk
Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
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|---|---|
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Skin and subcutaneous tissue disorders
Tingling
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46.2%
6/13 • Number of events 6 • Weekly during the one month of at home cranial electrotherapy stimulation
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Skin and subcutaneous tissue disorders
Skin redness
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15.4%
2/13 • Number of events 2 • Weekly during the one month of at home cranial electrotherapy stimulation
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Musculoskeletal and connective tissue disorders
Neck pain
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7.7%
1/13 • Number of events 1 • Weekly during the one month of at home cranial electrotherapy stimulation
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Ear and labyrinth disorders
Ringing in ears
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23.1%
3/13 • Number of events 3 • Weekly during the one month of at home cranial electrotherapy stimulation
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Psychiatric disorders
Mood changes
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30.8%
4/13 • Number of events 4 • Weekly during the one month of at home cranial electrotherapy stimulation
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Nervous system disorders
Difficulties concentrating
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0.00%
0/13 • Weekly during the one month of at home cranial electrotherapy stimulation
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Nervous system disorders
Feeling drowsy
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15.4%
2/13 • Number of events 2 • Weekly during the one month of at home cranial electrotherapy stimulation
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Nervous system disorders
Phosphenes
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7.7%
1/13 • Number of events 1 • Weekly during the one month of at home cranial electrotherapy stimulation
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Nervous system disorders
Dizziness
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23.1%
3/13 • Number of events 3 • Weekly during the one month of at home cranial electrotherapy stimulation
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Nervous system disorders
Nausea
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7.7%
1/13 • Number of events 1 • Weekly during the one month of at home cranial electrotherapy stimulation
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place