Trial Outcomes & Findings for Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia (NCT NCT02975973)
NCT ID: NCT02975973
Last Updated: 2020-11-25
Results Overview
Change from Baseline to week 1 as measured by modulation of fMRI BOLD signal in DLPFC in the context of cognitive control task performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
1 week
Results posted on
2020-11-25
Participant Flow
The reason we have fewer subjects randomized than enrolled is that some participants did not meet criteria to be randomized. These subjects were consented and completed many assessments, but were ultimately not randomized due to how they scored on some assessments. For instance, some peoples MCCB score was too high to be randomized into the study.
The primary reasons for ineligibility were not meeting the early psychosis criterion (\< 5 years of treatment), not taking any medication, and drug use. There were also many who did not even enter screening due to the assessment that they would highly likely not meet the threshold of requirement cognitive impairment (MATRICS score 40).
Participant milestones
| Measure |
2.5mA
Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
2.0mA
Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
1.5mA
Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
0mA (Active Placebo)
This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
1
|
4
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
2.5mA
Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
2.0mA
Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
1.5mA
Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
0mA (Active Placebo)
This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia
Baseline characteristics by cohort
| Measure |
2.5mA
n=1 Participants
Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
2.0mA
n=2 Participants
Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
1.5mA
n=1 Participants
Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
0mA (Active Placebo)
n=4 Participants
This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 0 • n=5 Participants
|
26 years
STANDARD_DEVIATION 3.65 • n=7 Participants
|
22 years
STANDARD_DEVIATION 0 • n=5 Participants
|
23 years
STANDARD_DEVIATION 2.44 • n=4 Participants
|
24 years
STANDARD_DEVIATION 2.66 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 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
|
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
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
MCCB Score
|
15 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 4.95 • n=7 Participants
|
35 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
32 units on a scale
STANDARD_DEVIATION 12.72 • n=4 Participants
|
26.6 units on a scale
STANDARD_DEVIATION 11.94 • n=21 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Our analytic strategy involved defining regions of interest (ROI) derived from group averages across all study subjects but due to unforeseen circumstances, we recruited far too few subjects to derive meaningful group averages. Individual subject and by extension, condition-specific averages that are based on such ROIs, could therefore not be derived. However, we will upload our raw data to the National Data Archive to be accessed for any potential analyses with data pooled from other studies.
Change from Baseline to week 1 as measured by modulation of fMRI BOLD signal in DLPFC in the context of cognitive control task performance.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 weekPopulation: Our analytic strategy involved defining regions of interest (ROI) derived from group averages across all study subjects but due to unforeseen circumstances, we recruited far too few subjects to derive meaningful group averages. Individual subject and by extension, condition-specific averages that are based on such ROIs, could therefore not be derived. However, we will upload our raw data to the National Data Archive to be accessed for any potential analyses with data pooled from other studies.
Change from Baseline to week 1 as measured by EEG frontal gamma oscillations in the context of cognitive control task performance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 WeekPopulation: Our analytic strategy involved defining regions of interest (ROI) derived from group averages across all study subjects but due to unforeseen circumstances, we recruited far too few subjects to derive meaningful group averages. Individual subject and by extension, condition-specific averages that are based on such ROIs, could therefore not be derived. However, we will upload our raw data to the National Data Archive to be accessed for any potential analyses with data pooled from other studies.
Change from baseline to 1 week in DLPFC engagement across conditions (1.5 vs 2.0 vs 2.5 mA)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: Due to unforeseen circumstances, we were unable to sufficiently recruit enough subjects to complete the originals plans for analysis. The percentages below are the percent of subjects who completed each condition.
The percentage of participants able to complete the full study.
Outcome measures
| Measure |
2.5mA
n=1 Participants
Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
2.0mA
n=2 Participants
Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
1.5mA
n=1 Participants
Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
0mA (Active Placebo)
n=4 Participants
This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
|---|---|---|---|---|
|
Tolerability and Feasibility of Multi-session tDCS in Schizophrenia
|
0 percentage of participants completed
|
50 percentage of participants completed
|
0 percentage of participants completed
|
100 percentage of participants completed
|
Adverse Events
2.5mA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2.0mA
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
1.5mA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0mA (Active Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5mA
n=1 participants at risk
Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
2.0mA
n=2 participants at risk
Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
1.5mA
n=1 participants at risk
Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
0mA (Active Placebo)
n=4 participants at risk
This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
|---|---|---|---|---|
|
Psychiatric disorders
Exacerbation of Psychotic Symptoms
|
0.00%
0/1 • Two Weeks
|
50.0%
1/2 • Number of events 1 • Two Weeks
|
0.00%
0/1 • Two Weeks
|
0.00%
0/4 • Two Weeks
|
Other adverse events
| Measure |
2.5mA
n=1 participants at risk
Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
2.0mA
n=2 participants at risk
Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
1.5mA
n=1 participants at risk
Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
0mA (Active Placebo)
n=4 participants at risk
This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.
transcranial direct current stimulation: transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor Burn
|
0.00%
0/1 • Two Weeks
|
50.0%
1/2 • Number of events 1 • Two Weeks
|
0.00%
0/1 • Two Weeks
|
0.00%
0/4 • Two Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place