Obsessive Compulsive DisorderNCT00029068
Cortical Excitability in Obsessive-Compulsive and Related Disorders
An observational study of Obsessive Compulsive Disorder and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will use transcranial magnetic stimulation (TMS) to study the function of the cerebral cortex (outer layer of the brain) in people with obsessive compulsive disorder (OCD) and related disorders. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder, Healthy
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Dec 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects will be screened for history of significant medical and non-OCD-related neuropsychiatric illnesses by means of a phone screening and interview with a trained screener (nurse, physician, social worker or psychologist).
- Each patient and healthy volunteer entered into the study must be free of significant medical or psychiatric illness and not taking any medications with neurological or psychotropic effects.
- The presence of neurological abnormalities will not be an exclusionary criterion because of the existence of lesional OCD \& OCD spectrum disorders that may co-exist with neurological disorders.
Who cannot join
- The only exclusionary criteria for this study are subjects who have a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects inside the eye or skull (for example, after brain surgery or a shrapnel wound) or any recent (less than 3 months) brain lesions.
- Subjects under 18 years of age will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Studies of Cortical Excitability in Obsessive-Compulsive Disorder, Related Disorder and Healthy Volunteers Using Paired-Pulse Transcranial Magnetic Stimulation
This study will use transcranial magnetic stimulation (TMS) to study the function of the cerebral cortex (outer layer of the brain) in people with obsessive compulsive disorder (OCD) and related disorders. A non-invasive procedure, TMS activates areas of the brain with magnetic pulses that travel through the scalp and head and cause small electrical currents in the brain.
People 18 years of age and older with OCD and disorders that may be related-tic disorders, such as Tourette's syndrome, focal dystonia (localized muscle cramps), body dysmorphic disorder (hypersensitivity to changes in appearance), eating disorders, such as anorexia nervosa, trichotillomania (compulsive hair-pulling)-may be eligible for this study. Healthy normal volunteers will also be enrolled. Candidates will be screened by telephone interview.
Read more
Participants will undergo TMS. For this procedure, an insulated wire coil is placed on the subject's head. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of muscles during stimulation is recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Subjects will receive fewer than 500 magnetic pulses, and the study will take less than 3 hours. Participants may repeat the procedure on several occasions, if they agree.
Read the detailed description
Transcranial magnetic stimulation (TMS), a noninvasive means of stimulating the brain through the scalp and skull, has become an important tool in neurophysiology and neuropsychiatry. The purpose of this project is (1) to use TMS as a probe of cortical excitability to investigate the physiology of the cerebral cortex in Obsessive-Compulsive Disorder (OCD) and OCD-related disorders (including the "OCD spectrum"), which we believe to be disorders involving alterations in the excitability of the cortex; (2) to compare those findings to results in healthy individuals, and (3) to evaluate the possible effects of various pharmacological treatments on TMS parameters in individuals with OCD and OCD-related disorders. This protocol seeks to evaluate the hypothesis that TMS may provide a sensitive measure of cortical function that is relevant to the underlying pathology in OCD and OCD-related disorders. The identification of possible anomalies of TMS measures in these patient groups and changes elicited by pharmaceutical agents will be useful in orienting research towards investigations of the cortical neurotransmitter systems.
- Conditions
- Obsessive Compulsive Disorder, Healthy
- Keywords
- Neurophysiology, Tourette Syndrome, Anorexia, SRIs, Personality, Obsessive-Compulsive Disorder (OCD), Cortical Excitability, Motor Cortex, Transcranial Magnetic Stimulation, OCD Spectrum Disorders, Obsessive Compulsive, OCD, Healthy Volunteer, Normal Control, HV
- Medical subject headings
- Obsessive-Compulsive Disorder, Tourette Syndrome, Anorexia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2002 (estimated)
- Study startJan 2002
- Study completionDec 2003
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 Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- 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
- 145 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029068
- Sponsor's protocol ID
- 020076
- Other IDs
- 02-M-0076
- Status last verified
- Dec 2003
- First submitted
- 4 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Alexander GE, DeLong MR, Strick PL. Parallel organization of functionally segregated circuits linking basal ganglia and cortex. Annu Rev Neurosci. 1986;9:357-81. doi: 10.1146/annurev.ne.09.030186.002041. No abstract available.
PubMed 3085570Baxter LR Jr, Schwartz JM, Bergman KS, Szuba MP, Guze BH, Mazziotta JC, Alazraki A, Selin CE, Ferng HK, Munford P, et al. Caudate glucose metabolic rate changes with both drug and behavior therapy for obsessive-compulsive disorder. Arch Gen Psychiatry. 1992 Sep;49(9):681-9. doi: 10.1001/archpsyc.1992.01820090009002.
PubMed 1514872Bihari K, Hill JL, Murphy DL. Obsessive-compulsive characteristics in patients with idiopathic spasmodic torticollis. Psychiatry Res. 1992 Jun;42(3):267-72. doi: 10.1016/0165-1781(92)90118-m.
PubMed 1496058
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Cortical Excitability in Obsessive-Compulsive Disorder, Related Disorder and Healthy Volunteers Using Paired-Pulse Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT00029068
- Acronym / sponsor ID
- 020076
- Conditions
- Obsessive Compulsive Disorder, Healthy
- Keywords
- Neurophysiology, Tourette Syndrome, Anorexia, SRIs, Personality, Obsessive-Compulsive Disorder (OCD), Cortical Excitability, Motor Cortex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Dec 2003
- First posted
- 7 Jan 2002 (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 use transcranial magnetic stimulation (TMS) to study the function of the cerebral cortex (outer layer of the brain) in people with obsessive compulsive disorder (OCD) and related disorders. A non-invasive procedure, TMS activates areas of the brain with magnetic pulses that travel through the scalp and head and cause small electrical currents in the brain.
People 18 years of age and older with OCD and disorders that may be related-tic disorders, such as Tourette's syndrome, focal dystonia (localized muscle cramps), body dysmorphic disorder (hypersensitivity to changes in appearance), eating disorders, such as anorexia nervosa, trichotillomania (compulsive hair-pulling)-may be eligible for this study. Healthy normal volunteers will also be enrolled. Candidates will be screened by telephone interview.
Participants will undergo TMS. For this procedure, an insulated wire coil is placed on the subject's head. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of muscles during stimulation is recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Subjects will receive fewer than 500 magnetic pulses, and the study will take less than 3 hours. Participants may repeat the procedure on several occasions, if they agree.
Detailed description
Transcranial magnetic stimulation (TMS), a noninvasive means of stimulating the brain through the scalp and skull, has become an important tool in neurophysiology and neuropsychiatry. The purpose of this project is (1) to use TMS as a probe of cortical excitability to investigate the physiology of the cerebral cortex in Obsessive-Compulsive Disorder (OCD) and OCD-related disorders (including the "OCD spectrum"), which we believe to be disorders involving alterations in the excitability of the cortex; (2) to compare those findings to results in healthy individuals, and (3) to evaluate the possible effects of various pharmacological treatments on TMS parameters in individuals with OCD and OCD-related disorders. This protocol seeks to evaluate the hypothesis that TMS may provide a sensitive measure of cortical function that is relevant to the underlying pathology in OCD and OCD-related disorders. The identification of possible anomalies of TMS measures in these patient groups and changes elicited by pharmaceutical agents will be useful in orienting research towards investigations of the cortical neurotransmitter systems.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be screened for history of significant medical and non-OCD-related neuropsychiatric illnesses by means of a phone screening and interview with a trained screener (nurse, physician, social worker or psychologist).
- Each patient and healthy volunteer entered into the study must be free of significant medical or psychiatric illness and not taking any medications with neurological or psychotropic effects.
- The presence of neurological abnormalities will not be an exclusionary criterion because of the existence of lesional OCD \& OCD spectrum disorders that may co-exist with neurological disorders.
Key exclusion criteria (2 listed)
- The only exclusionary criteria for this study are subjects who have a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects inside the eye or skull (for example, after brain surgery or a shrapnel wound) or any recent (less than 3 months) brain lesions.
- Subjects under 18 years of age 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 4 Mar 2008.
- Background: PubMed 3085570Alexander GE, DeLong MR, Strick PL. Parallel organization of functionally segregated circuits linking basal ganglia and cortex. Annu Rev Neurosci. 1986;9:357-81. doi: 10.1146/annurev.ne.09.030186.002041. No abstract available.
- Background: PubMed 1514872Baxter LR Jr, Schwartz JM, Bergman KS, Szuba MP, Guze BH, Mazziotta JC, Alazraki A, Selin CE, Ferng HK, Munford P, et al. Caudate glucose metabolic rate changes with both drug and behavior therapy for obsessive-compulsive disorder. Arch Gen Psychiatry. 1992 Sep;49(9):681-9. doi: 10.1001/archpsyc.1992.01820090009002.
- Background: PubMed 1496058Bihari K, Hill JL, Murphy DL. Obsessive-compulsive characteristics in patients with idiopathic spasmodic torticollis. Psychiatry Res. 1992 Jun;42(3):267-72. doi: 10.1016/0165-1781(92)90118-m.
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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 Obsessive Compulsive Disorder and Healthy, 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 3 inclusion and 2 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 4 Mar 2008. 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 NCT00029068, 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 4 Mar 2008.