Double Blind Trial of DC Polarization in FTD
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      Introduction: In a recent sham-controlled pilot study we showed that surface anodal DC
      polarization can improve verbal fluency in patients with frontotemporal dementia (FTD). This
      study is designed to extend those findings in a double blind trial. Objective: To see whether
      surface anodal DC polarization can improve verbal fluency and a global measure of behavior in
      FTD patients. Design: We propose to treat 20 FTD patients anodal and sham DC polarization in
      a double blind, crossover trial. Outcome Measures: The primary outcome measures are verbal
      fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral
      problems in dementia. Secondary outcomes will include a 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.
    

Intervention name(s): Anodal DC polarization of left prefrontal cortex
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Frontal Lobe; Language; Behavior; Degenerative Diseases; Pick's Disease; Frontotemporal Dementia; FTP