Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia
NCT ID: NCT05599373
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2020-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active rTMS over bilateral dorsolateral prefrontal cortex
Active rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Bilateral Active Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over bilateral dorsolateral prefrontal cortex (DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of each side resting motor threshold (MT). The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Active rTMS over left dorsolateral prefrontal cortex
Active rTMS over left dorsolateral prefrontal cortex and sham rTMS over right dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Left Active Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex(DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of left resting motor threshold (MT). Sham rTMS stimulation was delivered over right dorsolateral prefrontal cortex(DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Sham rTMS over bilateral dorsolateral prefrontal cortex
Sham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Sham rTMS over bilateral dorsolateral prefrontal cortex
Sham rTMS stimulation was delivered over bilateral dorsolateral prefrontal cortex (DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Interventions
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Bilateral Active Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over bilateral dorsolateral prefrontal cortex (DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of each side resting motor threshold (MT). The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Left Active Repetitive transcranial magnetic stimulation (rTMS)
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex(DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of left resting motor threshold (MT). Sham rTMS stimulation was delivered over right dorsolateral prefrontal cortex(DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Sham rTMS over bilateral dorsolateral prefrontal cortex
Sham rTMS stimulation was delivered over bilateral dorsolateral prefrontal cortex (DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 60.
* Patients with prominently negative symptoms, which was defined as: PANSS negative subscoreā„15 points and one of items N1-N7 scoringā„4.
* All patients were in stable clinical conditions (reduction rate of PANSS score\<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent.
Exclusion Criteria
* Unstable clinical condition (e.g., being aggressive and uncooperative).
* Current substance abuse.
* Any other psychiatric diagnosis.
* Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases.
* Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.
18 Years
60 Years
ALL
No
Sponsors
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Xuhui Mental Health Center
UNKNOWN
Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Yan Zhan, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Xuhui Mental Health Center
Locations
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Shanghai Xuhui Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XHJW2020KY003
Identifier Type: -
Identifier Source: org_study_id
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