Movement DisordersNCT00314444
Treatment for Psychogenic Disorders
An observational study of Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine whether biofeedback treatment is effective in lessening or stopping movement symptoms in people with psychogenic movement disorder. People with this condition have increased or decreased movements that are not under their control and are not associated with any know problem with the nervous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorders
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2006to 14 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically definite functional (psychogenic) movement disorder as defined by Fahn and Williams criteria diagnosed by a movement disorder neurologist.
- Patients who are at least 18 years old
- Able and willing to cooperate with the study requirements
Who cannot join
- Any underlying major medical or neurological conditions
- Patients whose movements are related to a known neurological disorder
- History of traumatic brain injury or history of strokes
- Current suicidal ideation
- Patients with a psychotic disorder
- Patients with active substance abuse within the last 6 months
Show all 9Show fewer
- Patients with moderate to severe depression, Beck Depression Inventory (BDI) greater than 18)
- Patients with any ongoing litigation related to their diagnosis of PMD.
- Patients with a definite overt stressor identified that is thought to be primarily responsible for the PMD symptoms
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: Treatment for Psychogenic Movement Disorders
This study will examine whether biofeedback treatment is effective in lessening or stopping movement symptoms in people with psychogenic movement disorder. People with this condition have increased or decreased movements that are not under their control and are not associated with any know problem with the nervous system. Biofeedback is a type of therapy that uses electronic instruments to monitor breathing and heart rate. This treatment has been effective in patients with anxiety and panic attacks.
People 18 years of age and older diagnosed with psychogenic movement disorder may be eligible for this study. Candidates are screened with a neurological history, physical examination and psychiatric evaluation.
Read more
Participants come to the NIH Clinical Center for nine 1-hour test sessions over an 8-week period for the following procedures:
Week 1 (two visits):
- Patients' movements are videotaped while they sit, stand and walk.
- Patients train on RESPeRATE device, a computerized musical biofeedback device to help slow theirs breathing rate. The device has three components: a computerized module, earphones, and a chest strap holding a breath sensor. The patients put the elastic strap around their chest, put on the earphones, and sit in a chair. The device monitors and analyzes their breathing to create a melody composed of two distinct tones - one for inhalation and one for exhalation. Patients are instructed to match their breathing to the tones, which gradually slow until they are breathing at a slower, therapeutic rate.
- Patients' breathing is monitored and analyzed for information on breathing pattern and rate.
- Patients complete questionnaires on level of relaxation before and after RESPeRATE training.
- Patients take the RESPeRATE device home to use for two 10-minute practice sessions per day. They complete relaxation questionnaires before and after each session.
Weeks 2-7:
- Patients' progress is monitored and reviewed from the previous week
- Patients' breathing is monitored and analyzed for information on breathing pattern and rate.
- Patients complete questionnaires on level of relaxation before and after RESPeRATE training.
- Patients are observed for 10 minutes while using the RESPeRATE device.
Week 8:
- Patients' progress is monitored and reviewed from the previous week
- Patients' breathing is monitored and analyzed for information on breathing pattern and rate.
- Patients complete questionnaires on level o...
Read the detailed description
Objective:
To apply respiratory biofeedback to patients with Psychogenic Movement Disorders (PMD) with a goal of decreasing involuntary movements.
Study Population:
Patients diagnosed with "clinically definite" PMD based on the Fahn-Williams scale
Design: Open-label pilot study
Outcome measures:
- To evaluate a possible decrease or resolution in involuntary movements caused by PMD as measured by the Psychogenic Movement Disorder Scale. Videotaping will be performed pre- and post-treatment and the videos will be evaluated by movement disorder specialists who are blinded to the pre-treatment or post-treatment condition.
- To evaluate if respiratory biofeedback is an effective treatment for patients with PMD.
- To retrospectively evaluate the components of anxiety and depression with responders versus non-responders.
- Conditions
- Movement Disorders
- Keywords
- Psychogenic, Psychogenic Movement Disorders
- Medical subject headings
- Movement Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study start7 Apr 2006
- Study completion14 Apr 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 Movement DisordersStudies 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
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314444
- Sponsor's protocol ID
- 060139
- Other IDs
- 06-N-0139
- Status last verified
- 14 Apr 2009
- First submitted
- 12 Apr 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Thomas M, Jankovic J. Psychogenic movement disorders: diagnosis and management. CNS Drugs. 2004;18(7):437-52. doi: 10.2165/00023210-200418070-00003.
PubMed 15139799Factor SA, Podskalny GD, Molho ES. Psychogenic movement disorders: frequency, clinical profile, and characteristics. J Neurol Neurosurg Psychiatry. 1995 Oct;59(4):406-12. doi: 10.1136/jnnp.59.4.406.
PubMed 7561921Anderson KE. Psychogenic Movement Disorders. Curr Treat Options Neurol. 2003 Mar;5(2):169-176. doi: 10.1007/s11940-003-0007-y.
PubMed 12628065
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
- Treatment for Psychogenic Movement Disorders
- ClinicalTrials.gov ID
- NCT00314444
- Acronym / sponsor ID
- 060139
- Conditions
- Movement Disorders
- Keywords
- Psychogenic, Psychogenic Movement Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 7 Apr 2006
- Study completion
- 14 Apr 2009
- First posted
- 13 Apr 2006 (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 whether biofeedback treatment is effective in lessening or stopping movement symptoms in people with psychogenic movement disorder. People with this condition have increased or decreased movements that are not under their control and are not associated with any know problem with the nervous system. Biofeedback is a type of therapy that uses electronic instruments to monitor breathing and heart rate. This treatment has been effective in patients with anxiety and panic attacks.
People 18 years of age and older diagnosed with psychogenic movement disorder may be eligible for this study. Candidates are screened with a neurological history, physical examination and psychiatric evaluation.
Participants come to the NIH Clinical Center for nine 1-hour test sessions over an 8-week period for the following procedures:
Week 1 (two visits):
- Patients' movements are videotaped while they sit, stand and walk.
- Patients train on RESPeRATE device, a computerized musical biofeedback device to help slow theirs breathing rate. The device has three components: a computerized module, earphones, and a chest strap holding a breath sensor. The patients put the elastic strap around their chest, put on the earphones, and sit in a chair. The device monitors and analyzes their breathing to create a melody composed of two distinct tones - one for inhalation and one for exhalation. Patients are instructed to match their breathing to the tones, which gradually slow until they are breathing at a slower, therapeutic rate.
- Patients' breathing is monitored and analyzed for information on breathing pattern and rate.
- Patients complete questionnaires on level of relaxation before and after RESPeRATE training.
- Patients take the RESPeRATE device home to use for two 10-minute practice sessions per day. They complete relaxation questionnaires before and after each session.
Weeks 2-7:
- Patients' progress is monitored and reviewed from the previous week
- Patients' breathing is monitored and analyzed for information on breathing pattern and rate.
- Patients complete questionnaires on level of relaxation before and after RESPeRATE training.
- Patients are observed for 10 minutes while using the RESPeRATE device.
Week 8:
- Patients' progress is monitored and reviewed from the previous week
- Patients' breathing is monitored and analyzed for information on breathing pattern and rate.
- Patients complete questionnaires on level o...
Detailed description
Objective:
To apply respiratory biofeedback to patients with Psychogenic Movement Disorders (PMD) with a goal of decreasing involuntary movements.
Study Population:
Patients diagnosed with "clinically definite" PMD based on the Fahn-Williams scale
Design: Open-label pilot study
Outcome measures:
- To evaluate a possible decrease or resolution in involuntary movements caused by PMD as measured by the Psychogenic Movement Disorder Scale. Videotaping will be performed pre- and post-treatment and the videos will be evaluated by movement disorder specialists who are blinded to the pre-treatment or post-treatment condition.
- To evaluate if respiratory biofeedback is an effective treatment for patients with PMD.
- To retrospectively evaluate the components of anxiety and depression with responders versus non-responders.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically definite functional (psychogenic) movement disorder as defined by Fahn and Williams criteria diagnosed by a movement disorder neurologist.
- Patients who are at least 18 years old
- Able and willing to cooperate with the study requirements
Key exclusion criteria (9 listed)
- Any underlying major medical or neurological conditions
- Patients whose movements are related to a known neurological disorder
- History of traumatic brain injury or history of strokes
- Current suicidal ideation
- Patients with a psychotic disorder
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 15139799Thomas M, Jankovic J. Psychogenic movement disorders: diagnosis and management. CNS Drugs. 2004;18(7):437-52. doi: 10.2165/00023210-200418070-00003.
- Background: PubMed 7561921Factor SA, Podskalny GD, Molho ES. Psychogenic movement disorders: frequency, clinical profile, and characteristics. J Neurol Neurosurg Psychiatry. 1995 Oct;59(4):406-12. doi: 10.1136/jnnp.59.4.406.
- Background: PubMed 12628065Anderson KE. Psychogenic Movement Disorders. Curr Treat Options Neurol. 2003 Mar;5(2):169-176. doi: 10.1007/s11940-003-0007-y.
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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 Movement Disorders, 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 3 inclusion and 9 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 NCT00314444, 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; AzTrials last refreshed its copy on 30 Oct 2026.