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Direct Current Brain Polarization in Frontotemporal Dementia

Primary Purpose

Pick Disease of the Brain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Direct Current Polarization
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 Pick Disease of the Brain focused on measuring Treatment, Transcranial Stimulation, Frontal Lobe, Pick's Disease, Cognitive Impairment, Dementia, Frontotemporal Dementia, FTD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: -Six patients referred to the Cognitive Neuroscience Section, NINDS, with a clinical diagnosis of FTD confirmed here, will be selected to participate in the study. EXCLUSION CRITERIA: Greater than 75 years of age. Presence of metal in the head other than dental hardware. Broken skin in the area of the stimulating electrodes. Any behavioral disorder that makes testing impossible. Children are excluded, as FTD is not a childhood illness.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 12, 2004
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00077896
Brief Title
Direct Current Brain Polarization in Frontotemporal Dementia
Official Title
Direct Current Brain Polarization in Frontotemporal Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This pilot study will evaluate the effect of direct current (DC) electrical polarization of the brain on language, memory, reaction time, and mood in six patients with frontotemporal dementia (Pick's disease). There is no effective treatment available for cognitive impairment in patients with this condition. DC polarization sends a very weak current between two sponge pads placed on the head. In a previous study in healthy volunteers, DC polarization of the left prefrontal area of the brain increased verbal fluency, memory and attention, and motor reaction time in the study subjects. Patients between 35 and 75 years of age with frontotemporal dementia who have been referred to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered participation in this study. Candidates will be screened with a neurological examination to confirm the diagnosis of frontotemporal dementia. Participants receive 40 minutes of DC polarization or sham polarization in each of two separate sessions. (No current is applied in the sham treatment). During the polarization, the patient rests quietly. Sponge pads that have been soaked in water are put on the left side of the head and above the right eye, and are held in place with elastic netting. Before the polarization and after about 20 minutes of polarization, patients undergo the following tests: Language: Patients must say as many words beginning with certain letters as they can in 90 seconds. Memory: Patients must remember a letter on a computer screen, and when the letter appears again, press the same letter on the keyboard. Reaction time: Patients place pegs on a pegboard. Mood: Patients place a mark on a line ranking how they feel.
Detailed Description
Introduction: In this study, we will use anodal direct current (DC) polarization at 2 mA to treat patients with frontotemporal dementia (FTD). Currently, there is no effective treatment for these patients. Previously, in healthy volunteers, we observed that DC polarization of the left prefrontal area for 20 min safely increases verbal fluency, cognitive processing speed (working memory and attention) and motor reaction speed. Both of these functions are severely impaired in FTD. Objective: We wish to see whether anodal DC polarization of the left prefrontal cortex in FTD patients leads to improvement in verbal fluency and working memory. Design: In this pilot study, we propose to treat six FTD patients for 40 min with anodal and sham DC polarization in a single-blind, crossover design. Outcome Measures: The main outcome measures will be verbal fluency and working memory. If anodal DC polarization produces clinically relevant improvements in these patients this will provide the impetus for a larger trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pick Disease of the Brain
Keywords
Treatment, Transcranial Stimulation, Frontal Lobe, Pick's Disease, Cognitive Impairment, Dementia, Frontotemporal Dementia, FTD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
6 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Direct Current Polarization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: -Six patients referred to the Cognitive Neuroscience Section, NINDS, with a clinical diagnosis of FTD confirmed here, will be selected to participate in the study. EXCLUSION CRITERIA: Greater than 75 years of age. Presence of metal in the head other than dental hardware. Broken skin in the area of the stimulating electrodes. Any behavioral disorder that makes testing impossible. Children are excluded, as FTD is not a childhood illness.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3808255
Citation
Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. doi: 10.1097/00006123-198701000-00030.
Results Reference
background
PubMed Identifier
12698316
Citation
Antal A, Kincses TZ, Nitsche MA, Paulus W. Manipulation of phosphene thresholds by transcranial direct current stimulation in man. Exp Brain Res. 2003 Jun;150(3):375-8. doi: 10.1007/s00221-003-1459-8. Epub 2003 Apr 16.
Results Reference
background
PubMed Identifier
11180425
Citation
Baudewig J, Nitsche MA, Paulus W, Frahm J. Regional modulation of BOLD MRI responses to human sensorimotor activation by transcranial direct current stimulation. Magn Reson Med. 2001 Feb;45(2):196-201. doi: 10.1002/1522-2594(200102)45:23.0.co;2-1.
Results Reference
background

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Direct Current Brain Polarization in Frontotemporal Dementia

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