HealthyNCT00001921
Electrophysiology and Blood Flow in Patients With Schizophrenia and Their Siblings
An observational study of Healthy and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties. Patients with schizophrenia and their unaffected family members are eligible for this study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Schizophrenia
- How many people
- 1,386 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 1999to 8 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Controls:
- No psychiatric or severe chronic medical illness at the time of the study, and by history. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories and medical conditions that are judged not to interfere with the study may be allowed.
- No use of psychotropic substances in the last 3 months.
- There is no upper age limit the lower age limit is 18 years.
- Patients:
- 1) Schizophrenia, any subtype or schizoaffective disorder according to DSM IV, as detailed in protocol # 89-M-0160 ("Inpatient evaluation of neuropsychiatric inpatients", Dr. Jose Apud, principal investigator) and # 95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients", Dr. Daniel R. Weinberger, principal investigator).
Who cannot join
- Controls and patients:
- Impaired hearing.
- Pregnancy (only for purpose of MRI procedures under separate protocols)
- Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. Patients or healthy volunteers with a known risk from exposure to high magnetic fields (e.g. patients with pace makers) and those who have metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans) will be excluded from participating in the fMRI studies.
- Patients:
- Coexistence of another major mental illness at the time of the study. If the patients experienced other mental illnesses in the past (e.g. a learning disability or major depression), then this should be judged to be fully recovered.
Show all 11Show fewer
- Criteria for substance abuse met in the last 6 months.
- Criteria for substance dependence met in the last year. If criteria for dependence were met in the past, then the duration of the disorder was less than 3 years, or not judged to have produced long-term brain changes to allow the patient to be in the study.
- Major concurrent medical illness likely to interfere with the acquisition of the task.
- Concomitant medications which could interfere with performance on the task.
- Presence of dyskinetic movements of the face and tongue (likely to interfere with eyeblink measures), or of gross involuntary movements of the whole body (likely to interfere with positioning in the MRI scanner).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Integrating EEG/MEG and fMRI: Activity Correlation Between Frontal and Temporal Lobe Structures in Schizophrenic Patients, Their Siblings and Unrelated Normal Volunteers
This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties.
Patients with schizophrenia and their unaffected family members are eligible for this study. Studying family members may help identify the genes related to the memory deficit in schizophrenia. Normal volunteers will also be studied.
Read more
Normal volunteers, patients with schizophrenia, and their family members interested in participating in this study will be screened with a complete medical examination and psychiatric assessment, and performance of simple tasks. Study participants will be shown numbers on a screen and asked to recall them after a brief period. This will be done during electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure the brain s electrical activity. The same test will be repeated while the patient has magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better localization of the brain s electrical activity.
...
Read the detailed description
It is the aim of this study to investigate the functional activation and coupling between brain regions in normals, patients with schizophrenia and unaffected family members. We will perform electrophysiological recordings (MEG, EEG) during cognitive activation (Continuous Performance Task, Sternberg paradigm, working memory). We will focus on the investigation of oscillatory brain activity as this is considered to be crucial for information processing related to neuronal integration. The measurements will be closely adapted to equivalent fMRI-measurements presented as an independent protocol (00-M-0085). The combination of both methods will help to improve activity source localization (MEG/EEG) and correlation of this activity between different parts of the brain. In addition, local activity patterns (fMRI) can be better characterized in the time domain (tonic versus phasic BOLD-activation). We will address whether cognitive activation goes along with an increase or decrease of correlation between regional brain areas. In this context, we will investigate whether this correlated activation pattern is different in schizophrenics and unaffected siblings when compared with normals. The study is integrated with the schizophrenia-sibling study (95-M-0150). Siblings of schizophrenic patients are investigated in order to achieve a better understanding of the genetic determination of schizophrenia-related pathophysiology.
- Conditions
- Healthy, Schizophrenia
- Keywords
- Functional Connectivity, Frontotemporal Interaction, Electrophysiology, Functional Magnetic Resonance Imaging, Healthy Subjects, Schizophrenia, MEG, Neuroimaging, EEG, MRI
- Medical subject headings
- Schizophrenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start21 Sep 1999
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,386 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karen F Berman, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001921
- Sponsor's protocol ID
- 990172
- Other IDs
- 99-M-0172
- Status last verified
- 8 Jun 2018
- First submitted
- 3 Nov 1999
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Rutter L, Nadar SR, Holroyd T, Carver FW, Apud J, Weinberger DR, Coppola R. Graph theoretical analysis of resting magnetoencephalographic functional connectivity networks. Front Comput Neurosci. 2013 Jul 12;7:93. doi: 10.3389/fncom.2013.00093. eCollection 2013.
PubMed 23874288Siebenhuhner F, Weiss SA, Coppola R, Weinberger DR, Bassett DS. Intra- and inter-frequency brain network structure in health and schizophrenia. PLoS One. 2013 Aug 26;8(8):e72351. doi: 10.1371/journal.pone.0072351. eCollection 2013.
PubMed 23991097Altamura M, Carver FW, Elvevag B, Weinberger DR, Coppola R. Dynamic cortical involvement in implicit anticipation during statistical learning. Neurosci Lett. 2014 Jan 13;558:73-7. doi: 10.1016/j.neulet.2013.09.043. Epub 2013 Sep 27.
PubMed 24080375Rubinstein DY, Eisenberg DP, Carver FW, Holroyd T, Apud JA, Coppola R, Berman KF. Spatiotemporal Alterations in Working Memory-Related Beta Band Neuromagnetic Activity of Patients With Schizophrenia On and Off Antipsychotic Medication: Investigation With MEG. Schizophr Bull. 2023 May 3;49(3):669-678. doi: 10.1093/schbul/sbac178.
PubMed 36772948
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating EEG/MEG and fMRI: Activity Correlation Between Frontal and Temporal Lobe Structures in Schizophrenic Patients, Their Siblings and Unrelated Normal Volunteers
- ClinicalTrials.gov ID
- NCT00001921
- Acronym / sponsor ID
- 990172
- Conditions
- Healthy, Schizophrenia
- Keywords
- Functional Connectivity, Frontotemporal Interaction, Electrophysiology, Functional Magnetic Resonance Imaging, Healthy Subjects, Schizophrenia, MEG, Neuroimaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,386 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 21 Sep 1999
- Study completion
- 8 Jun 2018
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties.
Patients with schizophrenia and their unaffected family members are eligible for this study. Studying family members may help identify the genes related to the memory deficit in schizophrenia. Normal volunteers will also be studied.
Normal volunteers, patients with schizophrenia, and their family members interested in participating in this study will be screened with a complete medical examination and psychiatric assessment, and performance of simple tasks. Study participants will be shown numbers on a screen and asked to recall them after a brief period. This will be done during electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure the brain s electrical activity. The same test will be repeated while the patient has magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better localization of the brain s electrical activity.
...
Detailed description
It is the aim of this study to investigate the functional activation and coupling between brain regions in normals, patients with schizophrenia and unaffected family members. We will perform electrophysiological recordings (MEG, EEG) during cognitive activation (Continuous Performance Task, Sternberg paradigm, working memory). We will focus on the investigation of oscillatory brain activity as this is considered to be crucial for information processing related to neuronal integration. The measurements will be closely adapted to equivalent fMRI-measurements presented as an independent protocol (00-M-0085). The combination of both methods will help to improve activity source localization (MEG/EEG) and correlation of this activity between different parts of the brain. In addition, local activity patterns (fMRI) can be better characterized in the time domain (tonic versus phasic BOLD-activation). We will address whether cognitive activation goes along with an increase or decrease of correlation between regional brain areas. In this context, we will investigate whether this correlated activation pattern is different in schizophrenics and unaffected siblings when compared with normals. The study is integrated with the schizophrenia-sibling study (95-M-0150). Siblings of schizophrenic patients are investigated in order to achieve a better understanding of the genetic determination of schizophrenia-related pathophysiology.
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- No psychiatric or severe chronic medical illness at the time of the study, and by history. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories and medical conditions that are judged not to interfere with the study may be allowed.
- No use of psychotropic substances in the last 3 months.
- There is no upper age limit the lower age limit is 18 years.
- 1) Schizophrenia, any subtype or schizoaffective disorder according to DSM IV, as detailed in protocol # 89-M-0160 ("Inpatient evaluation of neuropsychiatric inpatients", Dr. Jose Apud, principal investigator) and # 95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients", Dr. Daniel R. Weinberger, principal investigator).
Key exclusion criteria (11 listed)
- Impaired hearing.
- Pregnancy (only for purpose of MRI procedures under separate protocols)
- Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. Patients or healthy volunteers with a known risk from exposure to high magnetic fields (e.g. patients with pace makers) and those who have metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans) will be excluded from participating in the fMRI studies.
- Coexistence of another major mental illness at the time of the study. If the patients experienced other mental illnesses in the past (e.g. a learning disability or major depression), then this should be judged to be fully recovered.
- Criteria for substance abuse met in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 23874288Rutter L, Nadar SR, Holroyd T, Carver FW, Apud J, Weinberger DR, Coppola R. Graph theoretical analysis of resting magnetoencephalographic functional connectivity networks. Front Comput Neurosci. 2013 Jul 12;7:93. doi: 10.3389/fncom.2013.00093. eCollection 2013.
- Background: PubMed 23991097Siebenhuhner F, Weiss SA, Coppola R, Weinberger DR, Bassett DS. Intra- and inter-frequency brain network structure in health and schizophrenia. PLoS One. 2013 Aug 26;8(8):e72351. doi: 10.1371/journal.pone.0072351. eCollection 2013.
- Background: PubMed 24080375Altamura M, Carver FW, Elvevag B, Weinberger DR, Coppola R. Dynamic cortical involvement in implicit anticipation during statistical learning. Neurosci Lett. 2014 Jan 13;558:73-7. doi: 10.1016/j.neulet.2013.09.043. Epub 2013 Sep 27.
- Derived from this study: PubMed 36772948Rubinstein DY, Eisenberg DP, Carver FW, Holroyd T, Apud JA, Coppola R, Berman KF. Spatiotemporal Alterations in Working Memory-Related Beta Band Neuromagnetic Activity of Patients With Schizophrenia On and Off Antipsychotic Medication: Investigation With MEG. Schizophr Bull. 2023 May 3;49(3):669-678. doi: 10.1093/schbul/sbac178.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen F Berman, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001921, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.