Double Blind Trial of DC Polarization in FTD

Dementia Clinical Trial

Official title:

Double Blind Trial of DC Polarization in FTD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117858
• Other study ID #: 050180
• Secondary ID: 05-N-0180
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2005
• Last updated: June 30, 2017
• Start date: June 28, 2005
• Est. completion date: May 10, 2007

Study information

• Verified date: May 10, 2007
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 10, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

• INCLUSION CRITERIA

Patients must:

• meet diagnostic criteria for FTD (Knopman et al., 2005)

• be capable of understanding and cooperating with task instructions

• be fluent enough to generate at least three words in one category in one minute

• be between ages 35 to 75

• be right handed.

EXCLUSION CRITERIA

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

Related Conditions & MeSH terms

• Dementia

Intervention

Procedure:
• Anodal DC polarization of left prefrontal cortex

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.
Secondary	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.