Sep 30, 2015

Modafinil in the Treatment of Fatigue in Post-Polio Syndrome

This study, conducted at the Walter Reed Army Medical Center, the National Rehabilitation Hospital, and the National Institutes of Health, will examine whether the drug Modafinil can decrease fatigue in patients with post-polio syndrome. Many people who have had polio develop weakness and severe fatigue several years after their recovery from the acute disease. Modafinil is approved by the Food and Drug Administration to improve wakefulness in patients with narcolepsy (disease in which patients have excessive daytime sleepiness) and has been used to treat patients with fatigue related to other medical conditions, such as multiple sclerosis. This study will compare the effects of two doses of Modafinil and of a placebo (a pill with no active ingredient) on fatigue in patients with post-polio syndrome.
Patients who develop fatigue, weakness, muscle pain or atrophy, and functional loss at least 15 years after recovering from polio and whose symptoms cannot be attributed to another cause may be eligible for this study. Candidates will be screened with a medical history, physical and neurological examinations, fatigue rating scales, electrocardiogram, blood and urine tests, drowsiness and depression evaluations, and an electroymogram (EMG) to diagnose nerve or muscle problems. For the EMG, electrodes (small metal discs) are taped to the skin and a needle is inserted into a muscle to record the electrical activity.
Candidates will also undergo a sleep study to exclude abnormal sleep patterns as the cause of the fatigue. For this study, patients stay overnight at the NIH hospital. Electrodes are placed on the throat, on a finger, and on the chest (for an electrocardiogram), and a respiratory belt is placed around the chest-abdomen area. During sleep (from 10:30 p.m. to 6 a.m.), brain waves, eye and leg movements, muscle tone, respiration, and heart rate are recorded. Beginning at 8 a.m. the following morning, the patient takes 20-minute naps to measure the level of daytime sleepiness, using a recording technique similar to that of the all-night study. When five naps are completed, the sleep study ends. Candidates may also undergo a lumbar puncture (spinal tap) to check for certain chemicals in the spinal fluid that might be related to fatigue and to look for possible causes of post-polio syndrome. This procedure is optional. For the lumbar puncture, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle.
Patients enrolled in the study will complete a sleep diary during the entire study period. They will be randomly assigned to one of two treatment groups-Modafinil or placebo-for 6 weeks, followed by a 2-week washout period with no medication, and then a crossover phase, in which patients who took Modafinil for the first 6 weeks now take placebo, and those who took placebo now take Modafinil.
At the first study visit, patients will be given a supply of study medication and have blood drawn. They will take one pill twice a day during both study phases. In both study phases, evaluations will be done 3 and 6 weeks after starting the medication. The evaluations include filling out the same forms completed at the screening visit, a review of drug side effects, and a review of medical problems since the last study visit. At the 6-week visit, blood is also drawn.

Postpoliomyelitis SyndromeDrug: ModafinilPhase 3

Study Type:Interventional
Study Design:Primary Purpose: Treatment
Official Title:Modafinil in the Treatment of Fatigue in Post-Polio Syndrome

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Ascertain whether modafinil is of any benefit in alleviating the fatigue of Post-Polio Syndrome.

Post Polio Litaff, Association A.C _APPLAC Mexico

Sep 4, 2015

“I have value”: Brave polio survivor overcomes every obstacle -

“I have value”: Brave polio survivor overcomes every obstacle
Paralysed and uneducated, Barira spent 16 years believing she had no value. Still, she had a fierce desire to learn. With a little help, she has rebuilt her life, making many friends, and becoming an active part of her community. © UNFPA
NIAMEY, Niger – Barira Harouna, 16, is unlike any of other girl in her village, Bargaja, in Niger’s Maradi Region. At only 2 years old, she was paralyzed by polio. Two years later, her father died. Her mother soon remarried, leaving Barira with her grandmother. Not long afterward, Barira began begging outside a nearby store to help support their household.
She never enrolled in school and never travelled more than 100 metres from her home. Even getting to the store to beg was a trial. She had to crawl on all fours, using plastic sandals to protect her hands. And because of her disability, she confronted discrimination and derision everywhere she went.
"I watched the world go by,” she said. “I saw kids my age play and run throughout the day."
But in December 2014, everything changed. She enrolled in Ilimin Zama Dunia – known in English as the Action for Adolescent Girls Initiative – a non-formal education programme.
In the Illimin programme, Barira made friends for the first time in her life. Today, she often visits friends, relatives and community members. © UNFPA
Although Barira had been deprived of every opportunity to learn, her Illimin mentor, Rakia Sani, saw that she had great intellect and was powerfully motivated.
"She has a desire to understand and is actively engaged in the learning process. She has the right attitude to achieve her objectives, and pursues them despite the challenges,” Ms. Sani said, adding, “Barira is a fighter."

Lessons for life

Barira was one of 10,041adolescents enrolled in the December 2014 session of the programme, which brings together vulnerable girls for eight months of lessons on literacy, reproductive health, hygiene and human rights.
By helping the girls develop self-esteem, the courses are designed to empower the girls to refuse child marriage and avoid adolescent pregnancy. Supported by UNFPA, the Ministry of Population, Women’s Empowerment and Child Protection, and the NGO Lafia Matassa, Illimin aims to reach 250,000 adolescents between 2014 and 2018.
Sixty-four of the 10,041 girls had some type of disability, but only Barira and another girl, in the Tillabery Region, were unable to walk. Others had lower limb disabilities or were blind or could not hear. Some also had intellectual disabilities.
Despite their challenges, all of the 64 girls with disabilities were able to follow the lessons, attend the sessions regularly, and learn about their rights and their worth.

A new chapter

The experience was completely different from anything Barira had ever known. Tentatively, she made friends – the first in her life.
With Barira's new wheelchair, which she can pedal with her hands, she has gained new independence. © UNFPA
Still, she struggled to gain confidence. "My life has no meaning,” she told the mentors, sobbing, four months into the programme. “I am a burden on society. I am worthless because I cannot do anything. "
But by the eighth month, Barira began to feel comfortable. "I started to trust myself, to control my behaviour with others, and I felt re-valued. I discovered that I have talents and that I can be useful to myself, to my grandmother and even to society.”

A door to independence

A month before the end of the programme, an Illimin facilitator told Barira she would be receiving a wheelchair, provided by the UNFPA staff based in Maradi.
"When I broke the news to my grandmother, she jumped and danced with joy,” Barira said.
A few days later, on 13 June, she received the wheelchair at a ceremony attended by all the villagers. Together, Illumin staff and the village head placed it outside the door of her Barira’s home.
The wheelchair has three wheels, and is designed to let Barira navigate and accelerate with her hands. "When I took the first pedal strokes, I was filled with a sense of joy and wellness. The feelings of this new life have let me forget the past," she said.
Now, her life has completely changed. She has the confidence and the means to travel around the village and meet new people. "Today, I attend the various ceremonies in the village, and I visit relatives and friends," she told UNFPA.
“My disability is not an end in itself,” she said, “since I have value."
–Monique Clesca and Zoulaha Mato
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Post Polio Litaff, Association A.C _APPLAC Mexico

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