Trial Outcomes & Findings for Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia (NCT NCT01963676)
NCT ID: NCT01963676
Last Updated: 2016-02-22
Results Overview
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.
COMPLETED
NA
26 participants
Baseline, Day 5
2016-02-22
Participant Flow
Patients recruited through medical providers. Providers knew inclusion/exclusion criteria and discussed the study with patients during their regular appointments. Interested participants contacted the study team. Participants recruited from the STEP clinic (Chapel Hill and Raleigh), and the Burlington ACT team. Recruitment between 4/14 and 9/14.
Subjects randomly assigned to one of two groups, transcranial direct stimulation (tDCS) group or active sham group. tDCS group, direct current was delivered during awake, resting state for 20minutes on 5 consecutive days. Sham stimulation was delivered for an equal period of time and number of sessions. 27 subjects signed consent, 1 withdrew.
Participant milestones
| Measure |
Transcranial Direct Current Stimulation (tDCS)
13 subjects total. 2mA stimulation for 20 minutes.
tDCS
|
Sham Stimulation
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Transcranial Direct Current Stimulation (tDCS)
13 subjects total. 2mA stimulation for 20 minutes.
tDCS
|
Sham Stimulation
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=13 Participants
13 subjects total. 2mA stimulation for 20 minutes.
tDCS
|
Sham Stimulation
n=13 Participants
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.38 years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
40.00 years
STANDARD_DEVIATION 10.74 • n=7 Participants
|
41.69 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Auditory Hallucination Rating Scale
|
27.00 units on a scale
STANDARD_DEVIATION 6.90 • n=5 Participants
|
26.69 units on a scale
STANDARD_DEVIATION 6.30 • n=7 Participants
|
26.85 units on a scale
STANDARD_DEVIATION 6.48 • n=5 Participants
|
|
Positive and Negative Syndrome Scale
|
73.15 units on a scale
STANDARD_DEVIATION 12.90 • n=5 Participants
|
66.92 units on a scale
STANDARD_DEVIATION 17.17 • n=7 Participants
|
70.04 units on a scale
STANDARD_DEVIATION 15.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 5Population: Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=13 Participants
13 subjects total. 2mA stimulation for 20 minutes.
tDCS
|
Sham Stimulation
n=13 Participants
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation
|
|---|---|---|
|
Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
|
-6.38 units on a scale
Standard Deviation 6.38
|
-8.54 units on a scale
Standard Deviation 8.68
|
SECONDARY outcome
Timeframe: Day 5, One monthPopulation: Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.
We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation (tDCS)
n=13 Participants
13 subjects total. 2mA stimulation for 20 minutes.
tDCS
|
Sham Stimulation
n=13 Participants
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Sham stimulation
|
|---|---|---|
|
Persistence of Decrease in AHRS Score Over Time
|
-5.38 units on a scale
Standard Deviation 9.06
|
-4.77 units on a scale
Standard Deviation 8.26
|
Adverse Events
Transcranial Direct Current Stimulation (tDCS)
Sham Stimulation
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