Trial Outcomes & Findings for Targeting Auditory Hallucinations With Alternating Current Stimulation (NCT NCT03221270)
NCT ID: NCT03221270
Last Updated: 2022-02-16
Results Overview
The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assess frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
tACS Treatment & tACS Maintenance
10 Hz (alpha) transcranial alternating current stimulation (tACS) with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
5
|
6
|
|
Overall Study
Completed 5-Day Treatment
|
8
|
6
|
5
|
6
|
|
Overall Study
Completed 8-Week Maintenance
|
4
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Auditory Hallucinations With Alternating Current Stimulation
Baseline characteristics by cohort
| Measure |
tACS Treatment & tACS Maintenance
n=8 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
n=5 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
39.2 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.Population: Data for missing sessions was carried forward by replacing with the most recently completed session values.
The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assess frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations.
Outcome measures
| Measure |
tACS Treatment & tACS Maintenance
n=8 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
n=5 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
|---|---|---|---|---|
|
Mean Auditory Hallucination Rating Scale (AHRS) Score
Baseline (T1)
|
25.00 score on a scale
Standard Deviation 7.37
|
23.17 score on a scale
Standard Deviation 7.03
|
23.40 score on a scale
Standard Deviation 6.54
|
19.00 score on a scale
Standard Deviation 6.75
|
|
Mean Auditory Hallucination Rating Scale (AHRS) Score
End of 5-Day Treatment Week
|
25.13 score on a scale
Standard Deviation 8.01
|
21.00 score on a scale
Standard Deviation 5.93
|
25.60 score on a scale
Standard Deviation 6.84
|
19.83 score on a scale
Standard Deviation 5.08
|
|
Mean Auditory Hallucination Rating Scale (AHRS) Score
End of Maintenance
|
23.94 score on a scale
Standard Deviation 9.63
|
17.58 score on a scale
Standard Deviation 7.10
|
26.40 score on a scale
Standard Deviation 6.82
|
15.67 score on a scale
Standard Deviation 4.97
|
SECONDARY outcome
Timeframe: Change from baseline to immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.Population: Data for missing sessions was carried forward by replacing with the most recently completed session values.
Eyes-open but at rest EEG data was sampled using a 128-channel Geodesic EEG system. Alpha power spectral density was estimated using the Welch's method (in 2s Hamming windows with 0.5s overlap and 0.1 Hz spectral resolution). Aperiodic components were removed before extracting the individual alpha frequency (IAF; peak with the highest power density between 7 to 12 Hz, with consistent presence during the eyes-open blocks across all sessions). All spectra were visually inspected to confirm IAF choice. We computed the percent signal change of alpha power for each session relative to the baseline session:% change\_n=(P\_baseline-P\_n)/P\_baseline where P\_n is the alpha power in the n-th session, and P\_baseline is the alpha power in the baseline session.
Outcome measures
| Measure |
tACS Treatment & tACS Maintenance
n=8 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
n=5 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
|---|---|---|---|---|
|
Percentage of Signal Change in the Average Alpha Oscillation Power From Eyes-Open Resting State Electroencephalogram (EEG)
Average alpha power change from baseline to after 5 days of consecutive stimulation.
|
1.64 percentage of signal change
Standard Deviation 22.77
|
4.48 percentage of signal change
Standard Deviation 41.82
|
-11.64 percentage of signal change
Standard Deviation 21.00
|
18.62 percentage of signal change
Standard Deviation 35.98
|
|
Percentage of Signal Change in the Average Alpha Oscillation Power From Eyes-Open Resting State Electroencephalogram (EEG)
Average alpha power change from baseline to after the final stimulation session at week 8.
|
31.35 percentage of signal change
Standard Deviation 57.06
|
4.40 percentage of signal change
Standard Deviation 24.94
|
-22.21 percentage of signal change
Standard Deviation 14.70
|
40.96 percentage of signal change
Standard Deviation 50.40
|
SECONDARY outcome
Timeframe: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.Population: Data for missing sessions was carried forward by replacing with the most recently completed session values.
The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-administered scale. Each item is scored on a seven point scale, representing increasing levels of psychopathology (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme). Each item is rated in consultation with the definitions and criteria provided in the manual. Seven items constitute the positive scale, seven items make up the negative scale, and the remaining sixteen make up a general psychopathology scale. Therefore, the potential ranges are 7 to 49 for both positive and negative scales, and 16 to 112 for the General Psychopathology Scale.
Outcome measures
| Measure |
tACS Treatment & tACS Maintenance
n=8 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
n=5 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
|---|---|---|---|---|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean Positive Symptoms Scale at Baseline
|
19.5 score on a scale
Standard Deviation 4.4
|
16.8 score on a scale
Standard Deviation 5.4
|
18.0 score on a scale
Standard Deviation 2.7
|
19.0 score on a scale
Standard Deviation 6.8
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean Negative Symptoms Scale at Baseline
|
16.1 score on a scale
Standard Deviation 6.3
|
18.2 score on a scale
Standard Deviation 5.3
|
16.8 score on a scale
Standard Deviation 4.2
|
13.8 score on a scale
Standard Deviation 5.7
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean General Psychopathology Symptoms Scale at Baseline
|
36.5 score on a scale
Standard Deviation 11.5
|
31.0 score on a scale
Standard Deviation 11.6
|
33.0 score on a scale
Standard Deviation 5.0
|
27.7 score on a scale
Standard Deviation 7.1
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean Positive Symptoms Scale after 5 days of stimulation
|
18.6 score on a scale
Standard Deviation 4.0
|
17.3 score on a scale
Standard Deviation 5.2
|
16.6 score on a scale
Standard Deviation 3.4
|
17.2 score on a scale
Standard Deviation 4.7
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean Negative Symptoms Scale after 5 days of stimulation
|
15.5 score on a scale
Standard Deviation 5.1
|
17.7 score on a scale
Standard Deviation 3.5
|
17.6 score on a scale
Standard Deviation 6.5
|
15.0 score on a scale
Standard Deviation 7.0
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean General Psychopathology Symptoms Scale after 5 days of stimulation
|
32.0 score on a scale
Standard Deviation 8.4
|
29.7 score on a scale
Standard Deviation 10.3
|
22.6 score on a scale
Standard Deviation 2.4
|
26.0 score on a scale
Standard Deviation 5.7
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean Positive Symptoms Scale after 8 weeks of stimulation
|
18.3 score on a scale
Standard Deviation 3.9
|
15.7 score on a scale
Standard Deviation 5.2
|
17.2 score on a scale
Standard Deviation 2.17
|
17.0 score on a scale
Standard Deviation 3.2
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean Negative Symptoms Scale after 8 weeks of stimulation
|
16.3 score on a scale
Standard Deviation 5.3
|
15.5 score on a scale
Standard Deviation 5.0
|
16.8 score on a scale
Standard Deviation 4.4
|
15.7 score on a scale
Standard Deviation 6.8
|
|
Average Score on the Positive and Negative Syndrome Scales (PANSS)
Mean General Psychopathology Symptoms Scale after 8 weeks of stimulation
|
32.5 score on a scale
Standard Deviation 5.8
|
28.8 score on a scale
Standard Deviation 11.0
|
31.20 score on a scale
Standard Deviation 2.5
|
25.3 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.Population: Data for missing sessions was carried forward by replacing with the most recently completed session values.
The Brief Assessment of Cognition in Schizophrenia (BACS) is a clinically administered pen- and -paper battery of neurocognitive tests. The tasks administered in person included verbal memory, digit sequencing, token motor task, semantic fluency, letter fluency, symbol coding, and the tower of London task. The scores on each subtest were not normalized or scaled, values from each test were summed. In this sample the total summed scores ranged 112-296 with a standard deviation of 39.61. Higher values represent greater cognitive performance.
Outcome measures
| Measure |
tACS Treatment & tACS Maintenance
n=8 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
n=5 Participants
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
n=6 Participants
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
|---|---|---|---|---|
|
Brief Assessment Cognition in Schizophrenia (BACS)
Mean BACS at Baseline
|
194.63 units on a scale
Standard Deviation 34.45
|
184.00 units on a scale
Standard Deviation 31.82
|
220.40 units on a scale
Standard Deviation 39.51
|
215.00 units on a scale
Standard Deviation 25.91
|
|
Brief Assessment Cognition in Schizophrenia (BACS)
Mean BACS after five days of stimulation
|
208.38 units on a scale
Standard Deviation 44.75
|
188.17 units on a scale
Standard Deviation 22.14
|
243.20 units on a scale
Standard Deviation 45.10
|
208.33 units on a scale
Standard Deviation 48.70
|
|
Brief Assessment Cognition in Schizophrenia (BACS)
Mean BACS after 8 weeks of stimulation
|
210.00 units on a scale
Standard Deviation 52.21
|
194.83 units on a scale
Standard Deviation 24.20
|
235.40 units on a scale
Standard Deviation 49.20
|
220.17 units on a scale
Standard Deviation 30.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change across time from baseline measurement to final maintenance stimulationThe investigators will compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the 1st, 3rd, and final maintenance stimulation visits.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline AHRS at final maintenance stimulation session.The investigators will compare the AHRS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline PANSS at final maintenance stimulation session.The investigators will compare the PANSS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline BACS at final maintenance stimulation session.The investigators will compare the BACS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
tACS Treatment & tACS Maintenance
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham tACS Treatment & Sham tACS Maintenance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tACS Treatment & tACS Maintenance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
tACS Treatment & Sham tACS Maintenance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tACS Treatment & tACS Maintenance
n=8 participants at risk
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
Sham tACS Treatment & Sham tACS Maintenance
n=6 participants at risk
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
Sham tACS Treatment & tACS Maintenance
n=5 participants at risk
10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.
tACS sham week: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.
Maintenance tACS: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.
|
tACS Treatment & Sham tACS Maintenance
n=6 participants at risk
10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.
tACS treatment week: 10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.
Maintenance Sham tACS: 10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/6 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/5 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/6 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
|
Skin and subcutaneous tissue disorders
Burning Sensation on Scalp
|
25.0%
2/8 • Number of events 2 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/6 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/5 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/6 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
|
Musculoskeletal and connective tissue disorders
Muscular Pain
|
12.5%
1/8 • Number of events 1 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/6 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
20.0%
1/5 • Number of events 1 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
0.00%
0/6 • Adverse events were assessed at each visit during the 5-day treatment and the 8-week maintenance over an approximate 9-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the eighth maintenance treatment week.
|
Additional Information
Rachel Force, PhD
University of North Carolina at Chapel Hill
Phone: 984-974-6239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place