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Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms (tbTMS_SCH21)

Primary Purpose

Transcranial Magnetic Stimulation Repetitive, Schizophrenia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Magnetic Stimulation Repetitive

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. diagnosis of schizophrenia or schizoaffective disorder;
  2. clinically stabilized on antipsychotic: a stable dose of antipsychotic medication for >4 weeks;
  3. age 18-50 years, and
  4. presence of negative symptoms (based on PANSS): a negative subscore ≥16 points and [one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3]

Exclusion Criteria:

  1. any significant neurological illness;
  2. mental retardation
  3. history of head injury with loss of consciousness for more than 1 hour
  4. history of epileptic seizures or epileptic activity on the baseline EEG (evaluated by an expert in clinical EEG and epilepsy),
  5. alcohol or drug abuse within the past 3 months, and
  6. depressive episode or antidepressant treatment in the past 4 weeks.

Sites / Locations

  • Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Theta-burst rTMS

Sham stimulation

Arm Description

Theta-burst repetitive transcranial magnetic stimulation

Sham stimulation of the same location

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale, Negative subscore
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. It is the gold standard in the treatment monitoring of schizophrenia.The scale has three subscales : positive, negatve and general symptom score. We use the negative subscore as primary outcome. Its minimum and maximum scores are 7 and 49 respectively. Higher values indicate worse outcome.

Secondary Outcome Measures

Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests
They will be used to assess working memory. Digits Recalled is the primary outcome measure ranging between 2 and 10. Lower values indicate worse outcome.
Cognitive functioning/Executive functioning - Wisconsin Card Sorting test
The test will be used to measure cognitive flexibility/Executive functioning. Number of persevarative errors is the major outcome variable of the test, its minimum is 0, while it has no theroretical maximum value. Higher values indicate worse outcome. Punishment sensitivity (P) from the reinforcement learning model of WCST will also be used as outcome variable. Its minimum value is 0 and it has no theoretical maximum value. Lower values indicate worse outcome.
Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '
The total score is the primary outcome, which ranges between 0 and 37 points. Lower values indicate worse outcome.
Social cognition 2 - The 'Faux Pas' test.
Measures Theory of Mind (ToM), and the primary outcome measure is the total score, which ranges between 0 and 1. Lower values indicate worse outcome.
Facial Emotion Recogniton - Karolinska Directed Emotional Face set
Facial expression recognition task. Subject have to identify emotional expressions from photographs of 8 male and 8 female subjects. The pictures are chosen from Karolinska Directed Emotional Face set. There are 3 photographs from each faces (happy, neutral, and sad). Hit rate is the primary outcome measure, which ranges from 0% to 100%, and lower values indicate worse outcome.
Safety in terms of adverse events
Safety in terms of the number of serious adverse events (SAE). A Serious Adverse Event is any untoward medical occurrence that: Results in death Is life-threatening or Requires in-patient confinement or prolongation of existing confinement or Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect.

Full Information

First Posted
October 19, 2021
Last Updated
March 21, 2023
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05100888
Brief Title
Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms
Acronym
tbTMS_SCH21
Official Title
Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The major target of the study is to confirm the safety and efficacy of our augmented protocol of theta-burst TMS in schizophrenia. Our aim is to confirm the beneficial effects of rTMS treatment on multiple aspects of the disorder such as (1) clinical aspect in terms of PANSS, (2) cognitive aspect such as emotion recognition (ER) and working memory (WM) / distractor filtering (DF) performance, and (3) neurobiology in terms of electrophysiology correlates of ER, WM and DF such as event related theta synchronization, resting state theta power, and network connectivity. Response prediction to (theta-burst) TB-rTMS will be the exploratory part of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation Repetitive, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Theta-burst rTMS
Arm Type
Experimental
Arm Description
Theta-burst repetitive transcranial magnetic stimulation
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation of the same location
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Theta-burst stimulation
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale, Negative subscore
Description
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. It is the gold standard in the treatment monitoring of schizophrenia.The scale has three subscales : positive, negatve and general symptom score. We use the negative subscore as primary outcome. Its minimum and maximum scores are 7 and 49 respectively. Higher values indicate worse outcome.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests
Description
They will be used to assess working memory. Digits Recalled is the primary outcome measure ranging between 2 and 10. Lower values indicate worse outcome.
Time Frame
4 weeks
Title
Cognitive functioning/Executive functioning - Wisconsin Card Sorting test
Description
The test will be used to measure cognitive flexibility/Executive functioning. Number of persevarative errors is the major outcome variable of the test, its minimum is 0, while it has no theroretical maximum value. Higher values indicate worse outcome. Punishment sensitivity (P) from the reinforcement learning model of WCST will also be used as outcome variable. Its minimum value is 0 and it has no theoretical maximum value. Lower values indicate worse outcome.
Time Frame
4 weeks
Title
Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '
Description
The total score is the primary outcome, which ranges between 0 and 37 points. Lower values indicate worse outcome.
Time Frame
4 weeks
Title
Social cognition 2 - The 'Faux Pas' test.
Description
Measures Theory of Mind (ToM), and the primary outcome measure is the total score, which ranges between 0 and 1. Lower values indicate worse outcome.
Time Frame
4 weeks
Title
Facial Emotion Recogniton - Karolinska Directed Emotional Face set
Description
Facial expression recognition task. Subject have to identify emotional expressions from photographs of 8 male and 8 female subjects. The pictures are chosen from Karolinska Directed Emotional Face set. There are 3 photographs from each faces (happy, neutral, and sad). Hit rate is the primary outcome measure, which ranges from 0% to 100%, and lower values indicate worse outcome.
Time Frame
4 weeks
Title
Safety in terms of adverse events
Description
Safety in terms of the number of serious adverse events (SAE). A Serious Adverse Event is any untoward medical occurrence that: Results in death Is life-threatening or Requires in-patient confinement or prolongation of existing confinement or Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of schizophrenia or schizoaffective disorder; clinically stabilized on antipsychotic: a stable dose of antipsychotic medication for >4 weeks; age 18-55 years, and presence of negative symptoms (based on PANSS): a negative subscore ≥16 points and [one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3] Exclusion Criteria: any significant neurological illness; mental retardation history of head injury with loss of consciousness for more than 1 hour history of epileptic seizures or epileptic activity on the baseline EEG (evaluated by an expert in clinical EEG and epilepsy), alcohol or drug abuse within the past 3 months, and depressive episode or antidepressant treatment in the past 4 weeks. Severe positive symptoms inferfere with cognitive tests ECT in the medical history Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device Skin surface is severly injured in the stimulated region of the skull Sclerosis multiplex Pregnancy Severe sleep deprivation Severe heart failure Increased intracranial pressure Untreated migrain
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy
City
Budapest
ZIP/Postal Code
1083
Country
Hungary

12. IPD Sharing Statement

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Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms

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