NCT00077896

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2005

First QC Date

February 12, 2004

Last Update Submit

March 3, 2008

Conditions

Pick Disease of the Brain

Keywords

TreatmentTranscranial StimulationFrontal LobePick's DiseaseCognitive ImpairmentDementiaFrontotemporal DementiaFTD

Interventions

Direct Current PolarizationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 3808255BACKGROUND

  • 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.

    PMID: 12698316BACKGROUND

  • 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.

    PMID: 11180425BACKGROUND

MeSH Terms

Conditions

Pick Disease of the BrainCognitive DysfunctionDementiaFrontotemporal Dementia

Condition Hierarchy (Ancestors)

Frontotemporal Lobar DegenerationBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 12, 2004

First Posted

February 13, 2004

Study Start

February 1, 2004

Study Completion

August 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-08

Locations

US(1)