NIH Clinical Research Studies

Protocol Number: 04-N-0122

Active Accrual, Protocols Recruiting New Patients

Title:
Direct Current Brain Polarization in Frontotemporal Dementia
Number:
04-N-0122
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.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility 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.

Special Instructions: Currently Not Provided
Keywords:
Treatment
Transcranial Stimulation
Frontal Lobe
Pick's Disease
Cognitive Impairment
Recruitment Keywords:
Dementia
Frontotemporal Dementia
FTD
Conditions:
Pick Disease of the Brain
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. PMID: 3808255

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. PMID: 12698316

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. PMID: 11180425

Active Accrual, Protocols Recruiting New Patients

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