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Sponsor study identifier
Secondary identifiers
interventional
6
1 country
1
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 12, 2004
Actual (reported)February 13, 2004
Actual (reported)August 2005
Date type not reportedThis date has not been verified as actual or estimated.
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892, United States
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.
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.
First Submitted
February 12, 2004
First Posted
February 13, 2004
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Last Updated
March 4, 2008
Record last verified: 2005-08
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Source: ClinicalTrials.gov.
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