Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077896
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-02-12
Brief Title:
Direct Current Brain Polarization in Frontotemporal Dementia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Direct Current Brain Polarization in Frontotemporal Dementia
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Picks 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 NINDSs 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
Patients between 35 and 75 years of age with frontotemporal dementia who have been referred to NINDSs 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
Detailed Description:
Introduction In this study we will use anodal direct current DC polarization at 2 mA to treat patients with frontotemporal dementia FTD Currently there is no effective treatment for these patients Previously in healthy volunteers we observed that DC polarization of the left prefrontal area for 20 min safely increases verbal fluency cognitive processing speed working memory and attention and motor reaction speed Both of these functions are severely impaired in FTD Objective We wish to see whether anodal DC polarization of the left prefrontal cortex in FTD patients leads to improvement in verbal fluency and working memory Design In this pilot study we propose to treat six FTD patients for 40 min with anodal and sham DC polarization in a single-blind crossover design Outcome Measures The main outcome measures will be verbal fluency and working memory If anodal DC polarization produces clinically relevant improvements in these patients this will provide the impetus for a larger trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0122 | None | None | None |