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NCT00077896 · ClinicalTrials.gov registry record · Phase 1
Direct Current Brain Polarization in Frontotemporal Dementia
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00077896 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 6 participants.
The verdict
NCT00077896, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Direct Current Polarization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00077896
The ClinicalTrials.gov registry entry for NCT00077896 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Direct Current Polarization is the first listed.
NCT00077896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00077896 about?
NCT00077896 is a clinical study titled "Direct Current Brain Polarization in Frontotemporal Dementia". 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 c...
What is the current status of trial NCT00077896?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2004-02. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00077896?
The interventions under investigation include: Direct Current Polarization (PROCEDURE).
Who is sponsoring clinical trial NCT00077896?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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