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Vol. LX, No. 8
April 18, 2008

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Iraqi Woman Has Early Success in Dysphagia Study

On the front page...

Since suffering a stroke in May 2003, Sanaa Ibrahim—an Iraqi pharmacist and mother of three—had been unable to swallow anything. For 4 years she tried numerous treatments to no avail. Her search for an effective therapy led her to the United States, where she eventually entered Dr. Christy Ludlow’s clinical trial, “Comparison of an Implanted Neuroprosthesis with Sensory Training for Improving Airway Protection in Chronic Dysphagia.” Today Ibrahim is nearly back to normal.

“This experiment has changed my life,” she said. “I was using a feeding tube through my stomach to eat. I couldn’t even taste the food


  Sanaa Ibrahim can eat and drink again, thanks to an NINDS study.  
  Sanaa Ibrahim can eat and drink again, thanks to an NINDS study.  

But now I am almost back to normal. I got rid of the feeding tube and I can taste food and drinks, and eat in public with my family again.”

Although it is too early to declare the study a success, cautions principal investigator Ludlow, a senior scientist in the laryngeal and speech section of NINDS’s Medical Neurology Branch, the results thus far are promising.

Begun in April 2007, the study evaluates two devices to find which is better at improving swallowing and reducing the risk of choking in people who develop chronic swallowing problems after brain injury such as stroke. One device is an implanted stimulator that has a controller in the chest and can stimulate up to eight muscles to assist in swallowing. The other is a vibrotactile device that is strapped to the outside of the throat near the larynx and provides sensory stimulation when the user tries to swallow.

In the study, participants are randomized to one of the two device groups. Participants practice swallowing with their device set in patient-controlled mode each day for an hour and then use either device set in automatic mode or “saliva mode” to remind them to swallow every 3-5 minutes.

Dysphagia is a common disorder caused by brain damage following stroke, traumatic brain injury or tumor removal and is also seen in people with neurodegenerative disorders such as Parkinson’s disease. People with dysphagia have difficulty swallowing and may experience aspiration, i.e., food or liquid going into the windpipe while swallowing. Some people may be completely unable to swallow or may have trouble swallowing liquids, food or saliva.

According to Ludlow, people at risk of choking on fluid or food for several weeks or months face a significant risk of aspiration pneumonia and must be fed by tube with restricted intake by mouth. The survival rate in these cases is estimated to be only 17 percent after 3 years.

The goal of her study is to increase survival and quality of life for people with dysphagia by using the devices in an extensive retraining program to reduce the risk of aspiration and improve swallowing function. The study is significant because it is a unique approach to swallowing therapy. It involves teaching participants to retrain themselves to swallow in their own environment and with the help of their families.

“This is a highly intense program of swallowing retraining done by patients in their own homes every day for many months,” Ludlow explained. “This way they get practice on about 260 swallows each day. This is a different approach to traditional therapy. Currently, most patients get 1 hour per day for up to 2 weeks of swallowing therapy with a speech pathologist. [That] does not seem intense enough or long enough to retrain swallowing when it is lost following brain injury.”

As a participant in Dr. Christy Ludlow’s dysphagia study, Ibrahim uses a vibrotactile device to regain her swallowing and now is able to drink liquids and eat solid food again.
As a participant in Dr. Christy Ludlow’s dysphagia study, Ibrahim uses a vibrotactile device to regain her swallowing and now is able to drink liquids and eat solid food again.

The idea for the devices was developed based on years of studying the biomechanics of swallowing, experimental muscle stimulation and research looking at long-term muscle stimulation implants in animals. “We also found, through neuroimaging, that sensory stimulation will increase activity in the swallowing network in the brain, and we came up with the idea of using a sensory stimulator to help trigger swallowing,” said Ludlow.

Of the people who have entered the study thus far, two have reported partial success—one with the implant and the other using the vibrotactile device. “We haven’t had a chance to objectively re-evaluate any of the patients yet,” Ludlow noted.

According to Katie Dietrich-Burns, a research speech pathologist in the laryngeal and speech section and a member of Ludlow’s team, “Sanaa Ibrahim has been an ideal subject. She entered the study with realistic expectations. Her determination and supportive family keep her motivated and she continues to practice swallowing with the device on a consistent basis.”

Before entering the study, Ibrahim tried many other therapies including thermal and electrical stimulation, dilation and herbs. “It was useless,” she said. “I was using a feeding tube until I started this therapy, which cured me up to 80 percent after just 1 month of treatment. And now I can swallow fluids and semi-fluids. I removed the feeding tube and I am still using the device in hopes of regaining my swallowing 100 percent.”

Ibrahim, now living in Nigeria, continues to participate in the study because she has difficulty with saliva control. She now uses the vibrotactile device in the “saliva mode” to retrain control. Ludlow and Dietrich-Burns are evaluating and monitoring the progress of other study participants as well as recruiting new people for the study. NIHRecord Icon

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