Trial Outcomes & Findings for TDCS for Auditory Hallucinations in Schizophrenia (NCT NCT01898299)
NCT ID: NCT01898299
Last Updated: 2020-03-23
Results Overview
Total score: Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS). This is a seven item scale rating auditory hallucinations. Total score ranges from 1 to 41, with higher scores more severe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
Auditory Hallucination Rating Scale score after one month
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days
transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain.
|
Sham tDCS
Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.
Sham tDCS: Sham (inactive) tDCS treatment
|
|---|---|---|
|
Post Treatment (One Week)
STARTED
|
47
|
42
|
|
Post Treatment (One Week)
COMPLETED
|
47
|
42
|
|
Post Treatment (One Week)
NOT COMPLETED
|
0
|
0
|
|
Post Treatment (One Month)
STARTED
|
47
|
42
|
|
Post Treatment (One Month)
COMPLETED
|
44
|
38
|
|
Post Treatment (One Month)
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days
transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain.
|
Sham tDCS
Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.
Sham tDCS: Sham (inactive) tDCS treatment
|
|---|---|---|
|
Post Treatment (One Month)
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
TDCS for Auditory Hallucinations in Schizophrenia
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stimulation
n=47 Participants
Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days
transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain.
|
Sham tDCS
n=42 Participants
Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.
Sham tDCS: Sham (inactive) tDCS treatment
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
40.1 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
39.1 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Auditory Hallucination Rating Scale (AHRS) total score
|
24.8 units on a scale (total score)
STANDARD_DEVIATION 5.7 • n=99 Participants
|
25.2 units on a scale (total score)
STANDARD_DEVIATION 5.7 • n=107 Participants
|
25.0 units on a scale (total score)
STANDARD_DEVIATION 5.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Auditory Hallucination Rating Scale score after one monthPopulation: Population at one month
Total score: Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS). This is a seven item scale rating auditory hallucinations. Total score ranges from 1 to 41, with higher scores more severe.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=44 Participants
Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days
transcranial Direct Current Stimulation (tDCS): A neurostimulation technique that passes an extremely weak electric current through the brain.
|
Sham tDCS
n=38 Participants
Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.
Sham tDCS: Sham (inactive) tDCS treatment
|
|---|---|---|
|
Severity of Refractory Auditory Hallucinations
|
20.1 AHRS total score
Standard Deviation 9.9
|
23.1 AHRS total score
Standard Deviation 6.8
|
Adverse Events
Transcranial Direct Current Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place