Double Blind Trial of DC Polarization in FTD

NCT00117858 | Completed Phase 2

• 2 other identifiers: 05018005-N-0180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Frontal Lobe; Language; Behavior; Degenerative Diseases; Pick's Disease; Frontotemporal Dementia; FTP

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Anodal DC polarization of left prefrontal cortex PROCEDURE

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related 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. doi: 10.1212/01.WNL.0000152986.07469.E9.

  PMID: 15753425 BACKGROUND

MeSH Terms

Conditions

Dementia; Language; Behavior; Pick Disease of the Brain; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Communication; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 8, 2005
• Study Start: June 28, 2005
• Study Completion: May 10, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-05-10

Locations

US (1)