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NCT00117858 · ClinicalTrials.gov registry record · Phase 2
Double Blind Trial of DC Polarization in FTD
A Phase 2 study of Dementia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00117858 is a Phase 2 study of Dementia that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 20 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00117858, a Phase 2 study of Dementia, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE Anodal DC polarization of left prefrontal cortex
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-06-28 |
| Est. Completion | 2007-05-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00117858
The ClinicalTrials.gov registry entry for NCT00117858 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dementia appearing as the primary indexed condition, and to 1 intervention - of which Anodal DC polarization of left prefrontal cortex is the first listed.
NCT00117858 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00117858 about?
NCT00117858 is a clinical study titled "Double Blind Trial of DC Polarization in FTD". 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 ...
What is the current status of trial NCT00117858?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2005-06-28. Estimated completion is 2007-05-10.
What conditions does trial NCT00117858 study?
This clinical trial studies the following conditions: Dementia.
What interventions are being tested in trial NCT00117858?
The interventions under investigation include: Anodal DC polarization of left prefrontal cortex (PROCEDURE).
Who is sponsoring clinical trial NCT00117858?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00117858 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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