Post-Poliomyelitis SyndromeNCT00487487
Study of Mental Fatigue in Polio Survivors
An observational study of Post-Poliomyelitis Syndrome, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Poliomyelitis Syndrome
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- 18 years of age or older
- Be a survivor of poliomyelitis
- Willing to attend two clinic visits for completion of screening procedures and required tests
Who cannot join
- Suffer from medical conditions that can interfere with cognitive function, including stroke, traumatic brain injury, dementia (progressive memory loss), severe depression, psychosis or other psychiatric disorders, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Postpolio Syndrome Outpatient Research Office
Rockville, Maryland, 20852
Sandra Maxwell, RN, 301-984-0400, smaxwell@usuhs.edu
Olavo M Vasconcelos, MD
About this study
Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. The term "brain fatigue" is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant to examine if mental impairment is present in PPS patients and, if so, how it interferes on the self-function of patients. Patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. Patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. Through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.
- Conditions
- Post-Poliomyelitis Syndrome
- Keywords
- Candidates for this study are survivors of paralytic poliomyelitis
- Medical subject headings
- Postpoliomyelitis Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Poliomyelitis SyndromeStudies 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
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487487
- Sponsor's protocol ID
- USUHS-G192EI
- Status last verified
- Mar 2007
- First submitted
- 14 Jun 2007
- Last updated
- 18 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Mental Fatigue in Polio Survivors
- ClinicalTrials.gov ID
- NCT00487487
- Acronym / sponsor ID
- USUHS-G192EI
- Conditions
- Post-Poliomyelitis Syndrome
- Keywords
- Candidates for this study are survivors of paralytic poliomyelitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- First posted
- 18 Jun 2007 (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.
Post-Poliomyelitis Syndrome (PPS) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. Among the symptoms, fatigue is one of the most frequent and debilitating. In addition to physical incapacitation, the fatigue of PPS also affects mental function. The term "brain fatigue" is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. Unfortunately, little is known about cognitive fatigue of PPS patients. This study is meant to examine if mental impairment is present in PPS patients and, if so, how it interferes on the self-function of patients. Patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. Patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. Through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Be a survivor of poliomyelitis
- Willing to attend two clinic visits for completion of screening procedures and required tests
Key exclusion criteria (1 listed)
- Suffer from medical conditions that can interfere with cognitive function, including stroke, traumatic brain injury, dementia (progressive memory loss), severe depression, psychosis or other psychiatric disorders, etc.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2007.
Related trials for Post-Poliomyelitis Syndrome
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Nomad P-KAFO Study
Cerebrovascular Accident, Post-polio Syndrome
Active, not recruiting
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
Spinal Cord Injuries, Poliomyelitis
RecruitingObservational study
Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
ALS (Amyotrophic Lateral Sclerosis), Postpoliomyelitis Syndrome
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.
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 Post-Poliomyelitis Syndrome, run by Uniformed Services University of the Health Sciences 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 1 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: status not confirmed, as of the sponsor's last update on 18 Jun 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Maxwell, RN (301-9840400, smaxwell@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 18 Jun 2007.