Trial Outcomes & Findings for Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation (NCT NCT03037983)

Last Updated: 2024-08-15

Results Overview

Changes in scores for working memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves working memory. Working memory performance was assessed using a non-standardized task developed in house, which is basically a Sterberg style delayed response task in which memoranda are displayed and are to be remembered across a short delay period. The hypothesis will be supported if the investigators find greater working memory difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scores will be reported as a change in percent accuracy during this working memory task, where higher percent accuracy is better and scores range from -100% to 100%.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

before treatment and after 6-week treatment

Results posted on

2024-08-15

Participant Flow

Of the approached potential participants, many were unable to participate due to difficulties with the amount of time required to participate in the study, or a change in interest.

Participant milestones

Participant milestones
Measure	Active Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=5 Participants Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham n=4 Participants Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.	Total n=9 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
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 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	49.2 years STANDARD_DEVIATION 10.2 • n=5 Participants	40.5 years STANDARD_DEVIATION 14.5 • n=7 Participants	45.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Brief Assessment of Cognition in Schizophrenia (BACS) Composite T-score Score at Baseline	33.75 T-score STANDARD_DEVIATION 10.10 • n=5 Participants	33.5 T-score STANDARD_DEVIATION 10.66 • n=7 Participants	33.62 T-score STANDARD_DEVIATION 10.56 • n=5 Participants

PRIMARY outcome

Timeframe: before treatment and after 6-week treatment

Outcome measures

Outcome measures
Measure	Active n=5 Participants Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham n=4 Participants Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Change in Working Memory Function	-7.28 % change in Working Memory Task Accuracy Standard Deviation 12.95577091	-5.9 % change in Working Memory Task Accuracy Standard Deviation 15.55040192

PRIMARY outcome

Timeframe: before treatment and after 6-week treatment

Gamma oscillation is viewed as a measure of neurophysiologic function. The investigators will be conducting task-evoked electroencephalography (EEG) to measure gamma oscillation before and after rTMS. It is predicted that the intervention will improve gamma oscillations.

Outcome measures

Outcome measures
Measure	Active n=5 Participants Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham n=4 Participants Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Change in Neurophysiologic Function	0 wavelet coefficient in dB Standard Deviation .025	0 wavelet coefficient in dB Standard Deviation .03

PRIMARY outcome

Timeframe: before treatment and after 6-week treatment

Changes in Global Functioning Scale scores (GF) will serve as dependent measure for testing the hypothesis that rTMS improves functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scale's values range from a minimum score of 1 to a maximum score of 10, with a higher score means better functioning.

Outcome measures

Outcome measures
Measure	Active n=5 Participants Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham n=4 Participants Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Change in Level of Everyday Functioning	0 score on a scale Standard Deviation 3.1	-.5 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: before treatment and after 6-week treatment

Changes in Brief Assessment of Cognition (BACS) score will serve as a dependent measure for testing the hypothesis that rTMS improves cognitive functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Data will be reported as change in Z-score on the scale, where a higher value means a better outcome, with scores ranging from -3 to 3.

Outcome measures

Outcome measures
Measure	Active n=5 Participants Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham n=4 Participants Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Change in General Cognitive Ability	-.104 Z-score Standard Deviation .216	.505 Z-score Standard Deviation .374

Adverse Events

Active

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=5 participants at risk Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.	Sham n=4 participants at risk Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Psychiatric disorders Psychiatric Hospitalization	20.0% 1/5 • Adverse event data was collected for one month after the initiation of the intervention No difference in definitions used.	0.00% 0/4 • Adverse event data was collected for one month after the initiation of the intervention No difference in definitions used.

Other adverse events

Adverse event data not reported

Additional Information

Jong Yoon

Palo Alto VA

Phone: 510-220-7086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place