Trial Outcomes & Findings for Theta Burst Stimulation for Schizophrenia (NCT NCT03288779)

Last Updated: 2019-11-25

Results Overview

Performance on tasks included in the Brief Assessment of Cognition in Schizophrenia (BACS) battery, task performed and results recorded on IPAD. The mean change from baseline in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

30 minutes

Results posted on

2019-11-25

Participant Flow

We recruited 6 patients with diagnoses of schizophrenia, which included 4 inpatients and 2 outpatients.

Participant milestones

Participant milestones
Measure	Patients With a Diagnosis of Schizophrenia We recruited 6 patients with diagnoses of schizophrenia. Inpatient subjects were recruited towards the latter half of their inpatient stay, after their positive symptoms had decreased in severity. PANSS was performed at recruitment and subjects were chosen for the study only if their positive symptom score was less than or equal to 21. Our other inclusion criteria for the study were patients in the age group of 18-50 years, right handed, with no other comorbid DSM-5 diagnoses (including substance use disorder), and able to give informed consent. Subjects with organic basis for their psychopathology or intellectual disability, were excluded from the study. Intervention administered - Theta Burst Stimulation (TBS) with Brief Assessment of Cognition in Schizophrenia (BACS) administered before and after TBS.
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With a Diagnosis of Schizophrenia We recruited 6 patients with diagnoses of schizophrenia. Inpatient subjects were recruited towards the latter half of their inpatient stay, after their positive symptoms had decreased in severity. PANSS was performed at recruitment and subjects were chosen for the study only if their positive symptom score was less than or equal to 21. Our other inclusion criteria for the study were patients in the age group of 18-50 years, right handed, with no other comorbid DSM-5 diagnoses (including substance use disorder), and able to give informed consent. Subjects with organic basis for their psychopathology or intellectual disability, were excluded from the study. Intervention administered - Theta Burst Stimulation (TBS) with Brief Assessment of Cognition in Schizophrenia (BACS) administered before and after TBS.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Theta Burst Stimulation for Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With a Diagnosis of Schizophrenia n=6 Participants We recruited 6 patients with diagnoses of schizophrenia. Inpatient subjects were recruited towards the latter half of their inpatient stay, after their positive symptoms had decreased in severity. PANSS was performed at recruitment and subjects were chosen for the study only if their positive symptom score was less than or equal to 21. Our other inclusion criteria for the study were patients in the age group of 18-50 years, right handed, with no other comorbid DSM-5 diagnoses (including substance use disorder), and able to give informed consent. Subjects with organic basis for their psychopathology or intellectual disability, were excluded from the study.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age, Continuous	33 years STANDARD_DEVIATION 7 • n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	4 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	2 Participants n=39 Participants
Race (NIH/OMB) White	4 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	6 participants n=39 Participants
Brief Assessment of Cognition (BACS) Composite T Score	26.3 Composite T- Score STANDARD_DEVIATION 17.4 • n=39 Participants

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Outcome measures
Measure	Theta Burst Stimulation Arm n=3 Participants This is a pilot open label study. Theta Burst Stimulation: Transcranial magnetic stimulation with theta burst stimulation
Brief Assessment of Cognition (BACS) Composite T Score	37.33 Composite T- Score Interval 18.5 to 56.1

SECONDARY outcome

Timeframe: one session, approximately 30 minutes

Population: No EEG data was collected

Outcome measures

Outcome data not reported

Adverse Events

Patients With a Diagnosis of Schizophrenia

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

Steven T Szabo

DukeUMC

Phone: 3524540101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place