Double Blind Trial of DC Polarization in FTD
|ClinicalTrials.gov Identifier: NCT00117858|
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : July 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Procedure: Anodal DC polarization of left prefrontal cortex||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||Double Blind Trial of DC Polarization in FTD|
|Study Start Date :||June 28, 2005|
|Estimated Study Completion Date :||May 10, 2007|
- Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.
- Modified behavioral scale, administered every 12 hours during the study, a standard neurobehavioral rating scale, some experimental tests of dominant frontal lobe function and a control task that we do not expect to be affected.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117858
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|