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Double Blind Trial of DC Polarization in FTD

Primary Purpose

Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anodal DC polarization of left prefrontal cortex
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Frontal Lobe, Language, Behavior, Degenerative Diseases, Pick's Disease, Frontotemporal Dementia, FTP

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

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.

Full Information

First Posted
July 7, 2005
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00117858
Brief Title
Double Blind Trial of DC Polarization in FTD
Official Title
Double Blind Trial of DC Polarization in FTD
Study Type
Interventional

2. Study Status

Record Verification Date
May 10, 2007
Overall Recruitment Status
Completed
Study Start Date
June 28, 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 10, 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Frontal Lobe, Language, Behavior, Degenerative Diseases, Pick's Disease, Frontotemporal Dementia, FTP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Anodal DC polarization of left prefrontal cortex
Primary Outcome Measure Information:
Title
Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15753425
Citation
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. doi: 10.1212/01.WNL.0000152986.07469.E9.
Results Reference
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Double Blind Trial of DC Polarization in FTD

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