Back to resultsTMS Related Biomarker Assessments
Primary Purpose
Schizophrenia Schizoaffective, Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active rTMS first, then sham rTMS
sham rTMS first, then active rTMS
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia Schizoaffective focused on measuring schizophrenia, Transcranial magnetic stimulation
Eligibility Criteria
Inclusion Criteria: Male and Female between ages 18-65 Ability to give written informed consent (age 18 or above) Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above10. Exclusion Criteria: Any history of seizures. Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence. Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions. Taking > 400 mg clozapine/day Failed TMS screening questionnaire Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. History of head injury with loss of consciousness over 10 minutes; history of brain surgery Can not refrain from using alcohol and/or marijuana 24 hours or more & cigarette smoking half and hour or more prior to experiments. Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
Sites / Locations
- University of Maryland, BaltimoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Active rTMS first and sham rTMS second
Sham rTMS first and active rTMS second
Arm Description
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit.
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit.
Outcomes
Primary Outcome Measures
Change of resting-state functional connectivity (rsFC) by active and sham rTMS
TMS effect is obtained by comparing rsFC change from active and sham rTMS.
Change of mismatch negativity (MMN) from electroencephalography (EEG) signals by active and sham rTMS
TMS effect is explored by comparing MMN changes from active and sham rTMS. MMN is measured by subtracting the averaged EEG response to a set of standard stimuli from the averaged response to rarer deviant stimuli, and taking the amplitude of this difference wave in a given time window.
Secondary Outcome Measures
Full Information
NCT ID
NCT05660018
First Posted
December 2, 2022
Last Updated
March 30, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT05660018
Brief Title
TMS Related Biomarker Assessments
Official Title
TMS Related Biomarker Assessments
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration.
Detailed Description
Electrical neural oscillations of the brain can be measured at many levels, ranging from single cell to local field potentials in animals, to large-scale synchronized activities in the human scalp. New evidence suggests that there may be common underlying abnormalities in oscillatory activities that are associated with schizophrenia-related cognitive and functional impairments. There is currently no treatment for these electrical oscillation dysfunctions. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been approved by FDA for the treatment of depression and many other mental disorders. It has been used in a wide range of clinical research, especially in neurology and psychiatry. The investigators aim to develop TMS paradigms that will modulate brain responses during basic sensory to more complex cognitive performance and determine the parameters in anatomic locations and TMS modalities that may effectively and safely modulate neural activities. If the current experiments successfully identified TMS methods/paradigms that improve neural oscillation and cognitive performances in schizophrenia patients, in the future (not part of the current protocol), the investigators can then develop specific TMS treatment that may correct abnormal brain function and improve cognition and clinical symptoms of schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Schizoaffective, Schizophrenia
Keywords
schizophrenia, Transcranial magnetic stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS first and sham rTMS second
Arm Type
Other
Arm Description
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit.
Arm Title
Sham rTMS first and active rTMS second
Arm Type
Other
Arm Description
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit.
Intervention Type
Device
Intervention Name(s)
active rTMS first, then sham rTMS
Intervention Description
Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.
Intervention Type
Device
Intervention Name(s)
sham rTMS first, then active rTMS
Intervention Description
Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.
Primary Outcome Measure Information:
Title
Change of resting-state functional connectivity (rsFC) by active and sham rTMS
Description
TMS effect is obtained by comparing rsFC change from active and sham rTMS.
Time Frame
2 weeks
Title
Change of mismatch negativity (MMN) from electroencephalography (EEG) signals by active and sham rTMS
Description
TMS effect is explored by comparing MMN changes from active and sham rTMS. MMN is measured by subtracting the averaged EEG response to a set of standard stimuli from the averaged response to rarer deviant stimuli, and taking the amplitude of this difference wave in a given time window.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and Female between ages 18-65
Ability to give written informed consent (age 18 or above)
Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above10.
Exclusion Criteria:
Any history of seizures.
Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
Taking > 400 mg clozapine/day
Failed TMS screening questionnaire
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
History of head injury with loss of consciousness over 10 minutes; history of brain surgery
Can not refrain from using alcohol and/or marijuana 24 hours or more & cigarette smoking half and hour or more prior to experiments.
Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoming Du, PhD
Phone
410-402-6036
Email
xdu@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Tate
Phone
410-402-6008
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Du, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Du, PhD
Phone
410-402-6036
Email
xdu@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Kimberly Tate
Phone
4104026008
Email
KTate@som.umaryland.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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TMS Related Biomarker Assessments
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