Trial Outcomes & Findings for TMS Enhancement of Visual Plasticity in Schizophrenia (NCT NCT03220438)
NCT ID: NCT03220438
Last Updated: 2025-04-18
Results Overview
fMRI BOLD response in visual cortex, during visual stimulation (0.9 Hz) before and after high frequency visual stimulation (9 Hz).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
~1 hour
Results posted on
2025-04-18
Participant Flow
17 adults provided informed consent. 2 screen failures and 1 lost to follow-up before screening.
Participant milestones
| Measure |
TMS (Active Then Sham)
Participants first received active rTMS 10Hz to the occipital cortex and then 2 weeks later received sham (A sham coil was used to control for the auditory artifacts induced by rTMS)
TMS: Transcranial Magnetic Stimulation
|
TMS (Sham Then Active)
Participants first received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) and then 2 weeks later received active rTMS 10Hz to the occipital cortex
TMS: Transcranial Magnetic Stimulation
|
iTBS (Active Then Sham)
Participants first received active iTBS 5 Hz to the occipital cortex and then 2 weeks later received sham (a sham coil was used to control for the auditory artifacts induced by iTBS).
Intermittent theta-burst stimulation: iTBS
|
iTBA (Sham Then Active)
Participants first received sham (a sham coil was used to control for the auditory artifacts induced by iTBS) and then 2 weeks later received active iTBS 5 Hz to the occipital cortex .
Intermittent theta-burst stimulation: iTBS
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
6
|
5
|
|
Overall Study
COMPLETED
|
3
|
0
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
TMS (Active Then Sham)
Participants first received active rTMS 10Hz to the occipital cortex and then 2 weeks later received sham (A sham coil was used to control for the auditory artifacts induced by rTMS)
TMS: Transcranial Magnetic Stimulation
|
TMS (Sham Then Active)
Participants first received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) and then 2 weeks later received active rTMS 10Hz to the occipital cortex
TMS: Transcranial Magnetic Stimulation
|
iTBS (Active Then Sham)
Participants first received active iTBS 5 Hz to the occipital cortex and then 2 weeks later received sham (a sham coil was used to control for the auditory artifacts induced by iTBS).
Intermittent theta-burst stimulation: iTBS
|
iTBA (Sham Then Active)
Participants first received sham (a sham coil was used to control for the auditory artifacts induced by iTBS) and then 2 weeks later received active iTBS 5 Hz to the occipital cortex .
Intermittent theta-burst stimulation: iTBS
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
TMS Enhancement of Visual Plasticity in Schizophrenia
Baseline characteristics by cohort
| Measure |
TMS (Active Then Sham)
n=3 Participants
Participants first received active rTMS 10Hz to the occipital cortex and then 2 weeks later received sham (A sham coil was used to control for the auditory artifacts induced by rTMS)
|
TMS (Sham Then Active)
Participants first received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) and then 2 weeks later received active rTMS 10Hz to the occipital cortex
|
iTBS (Active Then Sham)
n=6 Participants
Participants first received active iTBS 5 Hz to the occipital cortex and then 2 weeks later received sham (a sham coil was used to control for the auditory artifacts induced by iTBS).
|
iTBS (Sham Then Active)
n=5 Participants
Participants first received sham (a sham coil was used to control for the auditory artifacts induced by iTBS) and then 2 weeks later received active iTBS 5 Hz to the occipital cortex
|
Total
n=14 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 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
|
33 years
STANDARD_DEVIATION 1 • n=5 Participants
|
—
|
32.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
33 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
32.77 years
STANDARD_DEVIATION 10.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 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
|
—
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 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=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
14 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: ~1 hourPopulation: 13 participants completed active and/or sham conditions for either TMS or iTBS
fMRI BOLD response in visual cortex, during visual stimulation (0.9 Hz) before and after high frequency visual stimulation (9 Hz).
Outcome measures
| Measure |
Patient: Active TMS 10 Hz
n=1 Participants
rTMS 10Hz to the occipital cortex
TMS: Transcranial Magnetic Stimulation
|
Patient: Sham TMS
n=1 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.
TMS: Transcranial Magnetic Stimulation
|
Patient: Active iTBS
n=7 Participants
iTBS 5 Hz to the occipital cortex
Intermittent theta-burst stimulation: iTBS
|
Patient: Sham iTBS
n=6 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS
Intermittent theta-burst stimulation: iTBS
|
Control: Active TMS 10 Hz
n=2 Participants
rTMS 10Hz to the occipital cortex
Transcranial Magnetic Stimulation: Transcranial Magnetic Stimulation
|
Control: Sham TMS
n=2 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.
TMS: Transcranial Magnetic Stimulation
|
Control: Active iTBS
n=3 Participants
iTBS 5 Hz to the occipital cortex
Intermittent theta-burst stimulation: iTBS
|
Control: Sham iTBS
n=3 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS
Intermittent theta-burst stimulation: iTBS
|
|---|---|---|---|---|---|---|---|---|
|
fMRI Blood Oxygenation Level Dependent (BOLD) Response of Visual Plasticity
|
-2.95 Beta values
Standard Deviation 0
|
-0.66 Beta values
Standard Deviation 0
|
-0.29 Beta values
Standard Deviation 2.55
|
2.57 Beta values
Standard Deviation 4.17
|
-0.7 Beta values
Standard Deviation 4.33
|
0.86 Beta values
Standard Deviation 2.33
|
-2.44 Beta values
Standard Deviation 3.27
|
2.47 Beta values
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: ~1 hourPopulation: 2 participants had missing data; 11 participants completed active and sham conditions for either TMS or iTBS
MRS was used to obtain occipital cortical glutamate levels (active, sham). Levels reflect institutional units, as is standard for the field.
Outcome measures
| Measure |
Patient: Active TMS 10 Hz
n=1 Participants
rTMS 10Hz to the occipital cortex
TMS: Transcranial Magnetic Stimulation
|
Patient: Sham TMS
n=1 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.
TMS: Transcranial Magnetic Stimulation
|
Patient: Active iTBS
n=7 Participants
iTBS 5 Hz to the occipital cortex
Intermittent theta-burst stimulation: iTBS
|
Patient: Sham iTBS
n=7 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS
Intermittent theta-burst stimulation: iTBS
|
Control: Active TMS 10 Hz
n=2 Participants
rTMS 10Hz to the occipital cortex
Transcranial Magnetic Stimulation: Transcranial Magnetic Stimulation
|
Control: Sham TMS
n=2 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.
TMS: Transcranial Magnetic Stimulation
|
Control: Active iTBS
n=1 Participants
iTBS 5 Hz to the occipital cortex
Intermittent theta-burst stimulation: iTBS
|
Control: Sham iTBS
n=1 Participants
A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS
Intermittent theta-burst stimulation: iTBS
|
|---|---|---|---|---|---|---|---|---|
|
Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate
|
8.96 spectroscopy institutional units
Standard Deviation NA
sd cannot be computed on 1 person
|
9.23 spectroscopy institutional units
Standard Deviation NA
sd cannot be computed on 1 person
|
9.34 spectroscopy institutional units
Standard Deviation 1.19
|
9.16 spectroscopy institutional units
Standard Deviation 1.15
|
10.61 spectroscopy institutional units
Standard Deviation 0.49
|
9.97 spectroscopy institutional units
Standard Deviation 0.07
|
12.04 spectroscopy institutional units
Standard Deviation NA
sd cannot be computed on 1 person
|
11.91 spectroscopy institutional units
Standard Deviation NA
sd cannot be computed on 1 person
|
Adverse Events
Active TMS 10 Hz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active iTBS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham iTBS
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