Actively Recruiting
An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
Led by Institute of Mental Health, Singapore · Updated on 2024-04-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of accelerated intermittent Theta Burst Stimulation (iTBS) as a new treatment approach for schizophrenia patients who continue to experience persistent negative symptoms, which are a major cause of ongoing difficulties even after recovery from acute psychotic episodes. This trial focuses on patients who have stable psychotic symptoms but dominant negative symptoms, aiming to assess if iTBS can improve these challenging symptoms where current treatments have limited effectiveness. Participants will receive an accelerated iTBS treatment targeting the left dorsolateral prefrontal cortex. This involves five daily sessions over five consecutive weekdays, totaling 25 sessions, with each session lasting about 10 minutes. The treatment uses specific stimulation parameters and is delivered by trained professionals following established guidelines. This open-label, single-arm study does not include a comparison group and follows patients immediately after treatment, as well as at 1 month and 3 months post-treatment. During the study, participants will undergo various clinical assessments including scales measuring negative symptoms, positive symptoms, cognitive function, depression, disability, and quality of life. The main outcome measured is the change in negative symptoms immediately after the treatment, with additional follow-ups to track symptom trends. The study aims to determine if this accelerated iTBS protocol can be effectively integrated into rehabilitation care for those with persistent negative symptoms in schizophrenia, with the potential for direct clinical application.
CONDITIONS
Brief Title
An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 65 years
- Diagnosis of schizophrenia or schizoaffective disorder
- Prominent and persistent negative symptoms with SANS score ≥3 or PANSS negative subscale score ≥20 in the past 6 months
- No clinically significant positive symptoms (PANSS positive subscale score <20)
- No clinically significant depressive symptoms (CDSS score <12)
- Able to give consent
You will not qualify if you...
- Current misuse of or dependence on illegal drugs or alcohol
- High suicide risk
- History of epileptic seizures
- Severe brain trauma, injury, or other neurological diseases
- Presence of metal implants in the skull
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week
Participants receive accelerated intermittent Theta Burst Stimulation (iTBS) sessions targeting the left dorsolateral prefrontal cortex or Frontal Medea.
5 sessions per day, every weekday, totaling 25 sessions
Duration - 3 months
Participants are monitored for changes in negative symptoms and overall progress after treatment.
Assessments immediately post treatment, at 1 month, and at 3 months post treatment
Trial Site Locations
Total: 1 location
1
Institute of Mental Health
Singapore, Singapore, 539747
Actively Recruiting
Research Team
X
Xiaowei Tan
H
Hasvinjit Kaur
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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