Double Blind Trial of DC Polarization in FTD
Completed · Phase 2
Conditions studied: Dementia
In brief
This project is designed to test how direct current (DC) electrical polarization of the brain affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the second most common form of dementia after Alzheimer's disease. It causes profound disturbances of language and other cognitive functions and often results in highly disruptive behavior. There is no effective treatment for the behavioral disorder or cognitive deficits in FTD. In an earlier study, the researchers used DC polarization to the primary motor cortex to enhance prefrontal function in healthy subjects. The experiment resulted in greater verbal fluency. In a separate study of five patients with FTD, a similar effect on verbal fluency was produced. The object of the current study is to replicate these findings in a larger group of patients and to see if the results carry over into "real world" behavior. Participants will be 20 patients aged 35 to 75 years with FTD, referred to the Cognitive Neuroscience Section. Participants will be tested in two sessions, separated by at least 48 hours. In one session they will receive 40 minutes of anodal DC polarization; in the other they will receive 40 minutes of sham polarization. Participants will be tested for language, memory, and reaction time before and 20 minutes after the polarization. For the behavior portion of the study, the Neuropsychiatric Inventory will be completed by an investigator with the caretaker on admission (covering the preceding week) and again, by telephone, 1 week after discharge, to cover the first week home. Participants will receive no lasting benefit as a result of the study, but the study is likely to yield generalizable knowledge on the effects of DC polarization treatment in FTD.
Key facts
- Study ID
- NCT00117858
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 20
- Starts
- 2005-06-28
- Expected to finish
- 2007-05-10
- Last updated by the study team
- 2017-07-02
Who can join
Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Presence of metal (prostheses, electrodes, other medical hardware, shrapnel) in the cranial cavity
- Broken skin in the area of the electrodes
- Inability to comprehend the experiment or to cooperate with treatment or testing
- Any uncontrolled medical problem
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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