CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Direct Current Polarizationprocedure
Likely dose
Not stated in record
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Search/NCT00077896
NCT00077896Phase 1Completed

Direct Current Brain Polarization in Frontotemporal Dementia

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Feb 13, 2004·Updated Mar 4, 2008

In Brief

A Phase 1 clinical trial evaluating Direct Current Polarization for Pick Disease of the Brain. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2004
Enrollment StartFeb 1, 2004
Study CompletionAug 1, 2005
TodayJul 2, 2026
Posted 22.4 years ago

Interventions

Direct Current Polarizationprocedure