SchizophreniaNCT00080548
Timing of Voluntary Movement in Patients With Schizophrenia
An observational study of Schizophrenia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine and compare how the brain controls the timing of movement in healthy volunteers and in people with schizophrenia. Previous experiments have shown that when people are asked to look at a clock and report the time they first decide to make a movement, they report times later than the first brain… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2004to 6 Jan 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SCHIZOPHRENIC PATIENTS:
- Experimental subjects will be patients with DSM-IV diagnosis of schizophrenia who have volunteered to participate in the clinical research unit of the Clinical Brain Disorders Branch, NIMH. In addition, outpatients with DSM-IV diagnosis of schizophrenia who participate in outpatient research through the CBDB will be included. All patients will have received the diagnosis of schizophrenia by means of the Structured Clinical Interview for DSM-IV (SCID) with three psychiatrists reaching a consensus diagnosis. Patients on the clinical research unit must meet rigorous criteria in order to participate in research. Exclusionary criteria include history of traumatic brain injury, known comorbid neurological disorders, including epilepsy, history of drug and alcohol abuse, etc. All patients will have undergone a comprehensive battery of neuropsychological tests, including Wide Range Achievement Test- Reading (often to be a good indicator of premorbid intelligence), a short version of Wechsler Adult Intelligence Scale (WAIS-R), Wechsler Memory Scales (WMS-R), Trails A and B, tests of attention and executive function, including the continuous performance test (CPT), Wisconsin Card Sort (WISC), the N-Back test of working memory. Patients with psychiatric diseases other than schizophrenia that are not currently active and symptomatic will be included.
- All patients in the study will have schizophrenia. However, at the time of testing, patients will be administered clinical rating scales (i.e., Brief Psychotic Rating Scale (BPRS), appropriate sections of the SCID and the Yale Hallucination Phenomenology Assessment (YHPA)) to determine the presence of passivity phenomena.
- NORMAL VOLUNTEERS:
- Twenty-six normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examinations. They will be asked to abstain from alcohol for 24 hours before the study. All subjects participating in the studies will have a valid Clinical Center Medical Record Number.
- ALL SUBJECTS:
- All subjects will be between the ages of 18 and 65. Subjects may be male or female.
Who cannot join
- Patients younger than 18 years old or older than 65 years old will be excluded from the study.
- Patients with neurological disorders will be excluded. Patients with psychiatric disorders other than schizophrenia who are experiencing an active phase of their disorder will be excluded.
- Patients with a history of significant medical disorders requiring chronic treatment with other drugs, which affect the central nervous system and cannot be stopped will be excluded.
- Patients not capable of giving an informed consent will be excluded.
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: Timing of Voluntary Movement in Patients With Schizophrenia Using EEG and Surface EMG
This study will examine and compare how the brain controls the timing of movement in healthy volunteers and in people with schizophrenia. Previous experiments have shown that when people are asked to look at a clock and report the time they first decide to make a movement, they report times later than the first brain waves associated with movement appear. When they are asked to report the time they first initiate the movement, they report times before the muscles actually begin to move. The study may help determine how the sense of willing and initiating an action is altered in schizophrenic patients, and how people may feel more or less "in control" of their movements.
Normal volunteers and patients with schizophrenia between 18 and 65 years of age may be eligible for this study. Control subjects must not have any neurological or psychological disorders, and schizophrenia patients must not have any other neurological disorders.
Read more
All participants will have a medical history, physical examination, and a test to determine their level of attention. Schizophrenia patients will be interviewed about their symptoms and complete psychiatric rating scales. In addition, all participants will undergo the following procedures:
Electric shock
Participants look at a clock on a computer screen whose hands revolves around the clock fast. While they look at the clock, they are given small, non-painful electric shocks and are asked to say when they receive the shocks, according to the clock. The shocks are repeated 40 times.
Arm movement
Participants are asked to lift their arm up off a table repeatedly, at random times, while they look at the computer clock. This exercise is repeated a total of 80 times. Of these 80 times, participants are asked 10 times in a row to say the time they first had the desire to move their arm, and then 10 times in a row the time they first felt that they were moving their arm.
Electroencephalography (EEG) and Electromyography (EMG)
Participants undergo EEG and EMG during the electric shock and arm movement experiments to measure electrical activity of the brain (EEG) and of the muscles (EMG). For EEG, electrodes (small metal discs) are placed on the scalp with a cap, paste, or glue-like substance and the brain waves are recorded. For EMG, electrodes are taped to the skin over the muscle.
Read the detailed description
Objectives
The purpose of this study is to determine how the subjective sense of willing and initiating an action is altered in schizophrenic patients. One proposed explanation for characteristic symptoms of schizophrenia ("passivity phenomena") is a defect in the forward model of movement that the brain receives as the motor signal is generated. We propose to examine this forward model using Libet's paradigm, in which normal subjects gave evidence for a forward model in their anticipatory reports of initiation of movement. We intend to determine the times associated with willing (W), initiating (M), and electroencephalographic/electromyographic (EEG/EMG) measures of movement.
Study Population
We intend to study adult patients with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of schizophrenia. These patients provide a unique population for this study because they often do not have the sense that they direct their own movement or author their own thoughts (passivity phenomena). Studies have shown that schizophrenics have movement-related cortical potentials on EEG, but it is not known when the subjective sense of initiating movement occurs for these patients. As the order of mental events in time has been shown to contribute to the sense of agency, it is important to know how the timing of voluntary movement is altered in schizophrenia.
Design
We will ask patients to look at a fast-rotating clock on a computer screen and note when their movements were willed, instigated by an external agent if they have such delusions, and were initiated. Patients will also report the time of a somatosensory stimulus. Surface EMG will determine the time of actual movement, and EEG will record brain potentials associated with movement. Eligible patients with schizophrenia and passivity phenomena will be recruited from the Clinical Brain Disorders Branch, NIMH.
Outcome Measures
The primary outcome measure of this study is the absence of time W in some schizophrenics, the latency of W in other schizophrenics compared to normal subjects, and the latency of M in schizophrenics compared to normals. Any effect of medication status or symptoms on performance in the study will be considered exploratory data.
- Conditions
- Schizophrenia
- Keywords
- Bereitschafts Potential, Timing of Volition, Somatic Passivity Phenomenon, Conscious Will, Libet's Clock, Schizophrenia, Healthy Volunteer, HV
- 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 posted7 Apr 2004 (estimated)
- Study start6 Apr 2004
- Study completion6 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)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
- 42 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080548
- Sponsor's protocol ID
- 040151
- Other IDs
- 04-N-0151
- Status last verified
- 6 Jan 2009
- First submitted
- 7 Apr 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Blakemore SJ, Smith J, Steel R, Johnstone CE, Frith CD. The perception of self-produced sensory stimuli in patients with auditory hallucinations and passivity experiences: evidence for a breakdown in self-monitoring. Psychol Med. 2000 Sep;30(5):1131-9. doi: 10.1017/s0033291799002676.
PubMed 12027049Chapman LJ, Chapman JP. The measurement of differential deficit. J Psychiatr Res. 1978;14(1-4):303-11. doi: 10.1016/0022-3956(78)90034-1. No abstract available.
PubMed 722633Frith CD, Done DJ. Experiences of alien control in schizophrenia reflect a disorder in the central monitoring of action. Psychol Med. 1989 May;19(2):359-63. doi: 10.1017/s003329170001240x.
PubMed 2762440
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Voluntary Movement in Patients With Schizophrenia Using EEG and Surface EMG
- ClinicalTrials.gov ID
- NCT00080548
- Acronym / sponsor ID
- 040151
- Conditions
- Schizophrenia
- Keywords
- Bereitschafts Potential, Timing of Volition, Somatic Passivity Phenomenon, Conscious Will, Libet's Clock, Schizophrenia, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 6 Apr 2004
- Study completion
- 6 Jan 2009
- First posted
- 7 Apr 2004 (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 examine and compare how the brain controls the timing of movement in healthy volunteers and in people with schizophrenia. Previous experiments have shown that when people are asked to look at a clock and report the time they first decide to make a movement, they report times later than the first brain waves associated with movement appear. When they are asked to report the time they first initiate the movement, they report times before the muscles actually begin to move. The study may help determine how the sense of willing and initiating an action is altered in schizophrenic patients, and how people may feel more or less "in control" of their movements.
Normal volunteers and patients with schizophrenia between 18 and 65 years of age may be eligible for this study. Control subjects must not have any neurological or psychological disorders, and schizophrenia patients must not have any other neurological disorders.
All participants will have a medical history, physical examination, and a test to determine their level of attention. Schizophrenia patients will be interviewed about their symptoms and complete psychiatric rating scales. In addition, all participants will undergo the following procedures:
Electric shock
Participants look at a clock on a computer screen whose hands revolves around the clock fast. While they look at the clock, they are given small, non-painful electric shocks and are asked to say when they receive the shocks, according to the clock. The shocks are repeated 40 times.
Arm movement
Participants are asked to lift their arm up off a table repeatedly, at random times, while they look at the computer clock. This exercise is repeated a total of 80 times. Of these 80 times, participants are asked 10 times in a row to say the time they first had the desire to move their arm, and then 10 times in a row the time they first felt that they were moving their arm.
Electroencephalography (EEG) and Electromyography (EMG)
Participants undergo EEG and EMG during the electric shock and arm movement experiments to measure electrical activity of the brain (EEG) and of the muscles (EMG). For EEG, electrodes (small metal discs) are placed on the scalp with a cap, paste, or glue-like substance and the brain waves are recorded. For EMG, electrodes are taped to the skin over the muscle.
Detailed description
Objectives
The purpose of this study is to determine how the subjective sense of willing and initiating an action is altered in schizophrenic patients. One proposed explanation for characteristic symptoms of schizophrenia ("passivity phenomena") is a defect in the forward model of movement that the brain receives as the motor signal is generated. We propose to examine this forward model using Libet's paradigm, in which normal subjects gave evidence for a forward model in their anticipatory reports of initiation of movement. We intend to determine the times associated with willing (W), initiating (M), and electroencephalographic/electromyographic (EEG/EMG) measures of movement.
Study Population
We intend to study adult patients with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of schizophrenia. These patients provide a unique population for this study because they often do not have the sense that they direct their own movement or author their own thoughts (passivity phenomena). Studies have shown that schizophrenics have movement-related cortical potentials on EEG, but it is not known when the subjective sense of initiating movement occurs for these patients. As the order of mental events in time has been shown to contribute to the sense of agency, it is important to know how the timing of voluntary movement is altered in schizophrenia.
Design
We will ask patients to look at a fast-rotating clock on a computer screen and note when their movements were willed, instigated by an external agent if they have such delusions, and were initiated. Patients will also report the time of a somatosensory stimulus. Surface EMG will determine the time of actual movement, and EEG will record brain potentials associated with movement. Eligible patients with schizophrenia and passivity phenomena will be recruited from the Clinical Brain Disorders Branch, NIMH.
Outcome Measures
The primary outcome measure of this study is the absence of time W in some schizophrenics, the latency of W in other schizophrenics compared to normal subjects, and the latency of M in schizophrenics compared to normals. Any effect of medication status or symptoms on performance in the study will be considered exploratory data.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Experimental subjects will be patients with DSM-IV diagnosis of schizophrenia who have volunteered to participate in the clinical research unit of the Clinical Brain Disorders Branch, NIMH. In addition, outpatients with DSM-IV diagnosis of schizophrenia who participate in outpatient research through the CBDB will be included. All patients will have received the diagnosis of schizophrenia by means of the Structured Clinical Interview for DSM-IV (SCID) with three psychiatrists reaching a consensus diagnosis. Patients on the clinical research unit must meet rigorous criteria in order to participate in research. Exclusionary criteria include history of traumatic brain injury, known comorbid neurological disorders, including epilepsy, history of drug and alcohol abuse, etc. All patients will have undergone a comprehensive battery of neuropsychological tests, including Wide Range Achievement Test- Reading (often to be a good indicator of premorbid intelligence), a short version of Wechsler Adult Intelligence Scale (WAIS-R), Wechsler Memory Scales (WMS-R), Trails A and B, tests of attention and executive function, including the continuous performance test (CPT), Wisconsin Card Sort (WISC), the N-Back test of working memory. Patients with psychiatric diseases other than schizophrenia that are not currently active and symptomatic will be included.
- All patients in the study will have schizophrenia. However, at the time of testing, patients will be administered clinical rating scales (i.e., Brief Psychotic Rating Scale (BPRS), appropriate sections of the SCID and the Yale Hallucination Phenomenology Assessment (YHPA)) to determine the presence of passivity phenomena.
- Twenty-six normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examinations. They will be asked to abstain from alcohol for 24 hours before the study. All subjects participating in the studies will have a valid Clinical Center Medical Record Number.
- All subjects will be between the ages of 18 and 65. Subjects may be male or female.
Key exclusion criteria (4 listed)
- Patients younger than 18 years old or older than 65 years old will be excluded from the study.
- Patients with neurological disorders will be excluded. Patients with psychiatric disorders other than schizophrenia who are experiencing an active phase of their disorder will be excluded.
- Patients with a history of significant medical disorders requiring chronic treatment with other drugs, which affect the central nervous system and cannot be stopped will be excluded.
- Patients not capable of giving an informed consent will be excluded.
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 2 Jul 2017.
- Background: PubMed 12027049Blakemore SJ, Smith J, Steel R, Johnstone CE, Frith CD. The perception of self-produced sensory stimuli in patients with auditory hallucinations and passivity experiences: evidence for a breakdown in self-monitoring. Psychol Med. 2000 Sep;30(5):1131-9. doi: 10.1017/s0033291799002676.
- Background: PubMed 722633Chapman LJ, Chapman JP. The measurement of differential deficit. J Psychiatr Res. 1978;14(1-4):303-11. doi: 10.1016/0022-3956(78)90034-1. No abstract available.
- Background: PubMed 2762440Frith CD, Done DJ. Experiences of alien control in schizophrenia reflect a disorder in the central monitoring of action. Psychol Med. 1989 May;19(2):359-63. doi: 10.1017/s003329170001240x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Schizophrenia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 7 inclusion and 4 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 2 Jul 2017. 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 NCT00080548, which also lists 3 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 2 Jul 2017.