Direct Current Brain Polarization in Frontotemporal Dementia

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ClinicalTrials.gov Identifier: NCT00077896

Recruitment Status : Completed

First Posted : February 13, 2004

Last Update Posted : March 4, 2008

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

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.

Condition or disease	Intervention/treatment	Phase
Pick Disease of the Brain	Procedure: Direct Current Polarization	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	6 participants
Primary Purpose:	Treatment
Official Title:	Direct Current Brain Polarization in Frontotemporal Dementia
Study Start Date :	February 2004
Study Completion Date :	August 2005

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: CHMP2B-related frontotemporal dementia GRN-related frontotemporal dementia Frontotemporal dementia with parkinsonism-17 Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia

MedlinePlus related topics: Dementia

Genetic and Rare Diseases Information Center resources: Frontotemporal Dementia Frontotemporal Dementia, Ubiquitin-positive Primary Progressive Aphasia Semantic Dementia Behavioral Variant of Frontotemporal Dementia

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077896

Locations

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United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

Publications:

Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7.

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. Epub 2003 Apr 16.

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.

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ClinicalTrials.gov Identifier:	NCT00077896 History of Changes
Other Study ID Numbers:	040122 04-N-0122
First Posted:	February 13, 2004 Key Record Dates
Last Update Posted:	March 4, 2008
Last Verified:	August 2005

Keywords provided by National Institutes of Health Clinical Center (CC):


Treatment Transcranial Stimulation Frontal Lobe Pick's Disease	Cognitive Impairment Dementia Frontotemporal Dementia FTD

Additional relevant MeSH terms:

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Dementia Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies	Neurodegenerative Diseases Proteostasis Deficiencies Metabolic Diseases Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms

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