Double Blind Trial of DC Polarization in FTD

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00117858
First received: July 7, 2005
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Dementia
Procedure: Anodal DC polarization of left prefrontal cortex
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Double Blind Trial of DC Polarization in FTD

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: June 2005
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117858

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00117858     History of Changes
Other Study ID Numbers: 050180, 05-N-0180
Study First Received: July 7, 2005
Last Updated: May 11, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Frontal Lobe
Language
Behavior
Degenerative Diseases
Pick's Disease
Frontotemporal Dementia
FTP

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014