Trial Outcomes & Findings for rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia (NCT NCT04182113)
NCT ID: NCT04182113
Last Updated: 2023-07-28
Results Overview
Change in estimated beta coefficients for the Target vs. Foil contrast during scene recognition in the precuneus. Beta coefficients reflect the strength of the blood oxygen-level dependent (BOLD) signal during each condition.Target images are those previously shown to participants, and Foil images have not been previously shown, as participants indicate whether they have been shown images. A higher measure indicates that the intervention increased brain activity during recognition of previously shown scenes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
1 day
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
rTMS Order 1
1 Hz rTMS Stimulation First, Then 20 Hz rTMS Stimulation, Then Sham rTMS
|
rTMS Order 2
1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation
|
rTMS Order 3
20 Hz rTMS Stimulation First, Then 1 Hz rTMS Stimulation, Then Sham rTMS
|
rTMS Order 4
20 Hz rTMS Stimulation First, Then Sham rTMS, Then 1 Hz rTMS Stimulation
|
rTMS Order 5
Sham rTMS First, Then 1 Hz rTMS Stimulation, Then 20 Hz rTMS Stimulation
|
rTMS Order 6
Sham rTMS first, then 20 Hz rTMS stimulation, then 1 Hz rTMS stimulation
|
|---|---|---|---|---|---|---|
|
First Intervention (Week 1)
STARTED
|
4
|
5
|
4
|
4
|
3
|
4
|
|
First Intervention (Week 1)
COMPLETED
|
4
|
5
|
4
|
4
|
3
|
4
|
|
First Intervention (Week 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (Week 2)
STARTED
|
4
|
5
|
4
|
4
|
3
|
4
|
|
Second Intervention (Week 2)
COMPLETED
|
4
|
5
|
4
|
4
|
3
|
4
|
|
Second Intervention (Week 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (Week 3)
STARTED
|
4
|
5
|
4
|
4
|
3
|
3
|
|
Third Intervention (Week 3)
COMPLETED
|
4
|
5
|
4
|
4
|
3
|
3
|
|
Third Intervention (Week 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia
Baseline characteristics by cohort
| Measure |
rTMS Order 4
n=4 Participants
20 Hz rTMS stimulation first, then sham rTMS, then 1 Hz rTMS stimulation
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
rTMS Order 1
n=4 Participants
1 Hz rTMS stimulation first, then 20 Hz rTMS stimulation, then sham rTMS
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
rTMS Order 2
n=5 Participants
1 Hz rTMS stimulation first, then sham rTMS, then 20 Hz rTMS stimulation
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
rTMS Order 3
n=4 Participants
20 Hz rTMS stimulation first, then 1 Hz rTMS stimulation, then sham rTMS
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
rTMS Order 5
n=3 Participants
Sham rTMS first, then 1 Hz rTMS stimulation, then 20 Hz rTMS stimulation
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
rTMS Order 6
n=4 Participants
Sham rTMS first, then 20 Hz rTMS stimulation, then 1 Hz rTMS stimulation
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
23.25 years
STANDARD_DEVIATION 3.59 • n=4 Participants
|
24 years
STANDARD_DEVIATION 4.08 • n=5 Participants
|
26 years
STANDARD_DEVIATION 3.08 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 4.43 • n=5 Participants
|
26 years
STANDARD_DEVIATION 8.54 • n=21 Participants
|
25.5 years
STANDARD_DEVIATION 2.38 • n=8 Participants
|
25.21 years
STANDARD_DEVIATION 4.08 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=21 Participants
|
4 participants
n=8 Participants
|
24 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 dayChange in estimated beta coefficients for the Target vs. Foil contrast during scene recognition in the precuneus. Beta coefficients reflect the strength of the blood oxygen-level dependent (BOLD) signal during each condition.Target images are those previously shown to participants, and Foil images have not been previously shown, as participants indicate whether they have been shown images. A higher measure indicates that the intervention increased brain activity during recognition of previously shown scenes.
Outcome measures
| Measure |
1 Hz rTMS
n=24 Participants
Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
|
20 Hz rTMS
n=24 Participants
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
|
Sham
n=23 Participants
Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
|---|---|---|---|
|
Change in Precuneus Functional Activation
|
0.0329 Beta coefficient change (Target vs Foil)
Standard Deviation 0.112
|
0.067 Beta coefficient change (Target vs Foil)
Standard Deviation 0.203
|
-0.010 Beta coefficient change (Target vs Foil)
Standard Deviation 0.112
|
PRIMARY outcome
Timeframe: 1 dayBlood oxygen level dependent (BOLD) signal functional connectivity with the precuneus in the bilateral dorsolateral prefrontal cortex, hippocampus, and anterior cingulate cortex. Value is the mean Fisher's transform of the correlation of BOLD time-series in the precuneus with the BOLD time-series in other named regions. Higher values indicate greater connectivity with the precuneus following the intervention. Value of zero indicates no relationship (no connectivity). This value has no unit of measurement.
Outcome measures
| Measure |
1 Hz rTMS
n=24 Participants
Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
|
20 Hz rTMS
n=24 Participants
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
|
Sham
n=23 Participants
Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
|---|---|---|---|
|
Precuneus Functional Connectivity
|
0.0657 Transformed correlation coefficient
Standard Deviation 0.0394
|
0.0482 Transformed correlation coefficient
Standard Deviation 0.0322
|
0.0566 Transformed correlation coefficient
Standard Deviation 0.0441
|
PRIMARY outcome
Timeframe: 1 dayPercent accuracy (0-100%) on detecting whether an image shown during a scene recognition was among those shown during the previous five-minute session. Higher scores indicate better performance in recalling images.
Outcome measures
| Measure |
1 Hz rTMS
n=24 Participants
Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
|
20 Hz rTMS
n=24 Participants
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
|
Sham
n=23 Participants
Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
|---|---|---|---|
|
Performance During In-scanner Episodic Memory Task
|
80.58 Percentage correct
Standard Deviation 15.4
|
76.63 Percentage correct
Standard Deviation 22.4
|
75.61 Percentage correct
Standard Deviation 20.0
|
Adverse Events
1 Hz rTMS Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
20 Hz rTMS Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham rTMS Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 Hz rTMS Stimulation
n=24 participants at risk
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
20 Hz rTMS Stimulation
n=24 participants at risk
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
Sham rTMS Stimulation
n=24 participants at risk
rTMS: Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
Sham: Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
|
|---|---|---|---|
|
Nervous system disorders
Numbness of fingers
|
0.00%
0/24 • 1 month
Investigator evaluated for adverse events at every visit
|
4.2%
1/24 • Number of events 1 • 1 month
Investigator evaluated for adverse events at every visit
|
0.00%
0/24 • 1 month
Investigator evaluated for adverse events at every visit
|
|
Musculoskeletal and connective tissue disorders
Application site discomfort
|
0.00%
0/24 • 1 month
Investigator evaluated for adverse events at every visit
|
0.00%
0/24 • 1 month
Investigator evaluated for adverse events at every visit
|
4.2%
1/24 • Number of events 1 • 1 month
Investigator evaluated for adverse events at every visit
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • 1 month
Investigator evaluated for adverse events at every visit
|
0.00%
0/24 • 1 month
Investigator evaluated for adverse events at every visit
|
0.00%
0/24 • 1 month
Investigator evaluated for adverse events at every visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place