DementiaPhase 2NCT00117858
Double Blind Trial of DC Polarization in FTD
A Phase 2 study testing Anodal DC polarization of left prefrontal cortex in people with Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This project is designed to test how direct current (DC) electrical polarization of the brain affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the second most common form of dementia after Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Dementia
- What is being tested?
- Anodal DC polarization of left prefrontal cortex
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2005to 10 May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must:
- meet diagnostic criteria for FTD (Knopman et al., 2005)
- be capable of understanding and cooperating with task instructions
- be fluent enough to generate at least three words in one category in one minute
- be between ages 35 to 75
- be right handed.
Who cannot join
- Presence of metal (prostheses, electrodes, other medical hardware, shrapnel) in the cranial cavity
- Broken skin in the area of the electrodes
- Inability to comprehend the experiment or to cooperate with treatment or testing
- Any uncontrolled medical problem
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This project is designed to test how direct current (DC) electrical polarization of the brain affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the second most common form of dementia after Alzheimer's disease. It causes profound disturbances of language and other cognitive functions and often results in highly disruptive behavior. There is no effective treatment for the behavioral disorder or cognitive deficits in FTD. In an earlier study, the researchers used DC polarization to the primary motor cortex to enhance prefrontal function in healthy subjects. The experiment resulted in greater verbal fluency. In a separate study of five patients with FTD, a similar effect on verbal fluency was produced. The object of the current study is to replicate these findings in a larger group of patients and to see if the results carry over into "real world" behavior.
Participants will be 20 patients aged 35 to 75 years with FTD, referred to the Cognitive Neuroscience Section.
Read more
Participants will be tested in two sessions, separated by at least 48 hours. In one session they will receive 40 minutes of anodal DC polarization; in the other they will receive 40 minutes of sham polarization. Participants will be tested for language, memory, and reaction time before and 20 minutes after the polarization. For the behavior portion of the study, the Neuropsychiatric Inventory will be completed by an investigator with the caretaker on admission (covering the preceding week) and again, by telephone, 1 week after discharge, to cover the first week home.
Participants will receive no lasting benefit as a result of the study, but the study is likely to yield generalizable knowledge on the effects of DC polarization treatment in FTD.
Read the detailed description
Introduction: In a recent sham-controlled pilot study we showed that surface anodal DC polarization can improve verbal fluency in patients with frontotemporal dementia (FTD). This study is designed to extend those findings in a double blind trial. Objective: To see whether surface anodal DC polarization can improve verbal fluency and a global measure of behavior in FTD patients. Design: We propose to treat 20 FTD patients anodal and sham DC polarization in a double blind, crossover trial. Outcome Measures: The primary outcome measures are verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia. Secondary outcomes will include a modified behavioral scale, administered every 12 hours during the study, a standard neurobehavioral rating scale, some experimental tests of dominant frontal lobe function and a control task that we do not expect to be affected.
- Conditions
- Dementia
- Being tested
- Anodal DC polarization of left prefrontal cortex
- Keywords
- Frontal Lobe, Language, Behavior, Degenerative Diseases, Pick's Disease, Frontotemporal Dementia, FTP
- Medical subject headings
- Dementia, Language, Behavior, Pick Disease of the Brain, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal DC polarization of left prefrontal cortexProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.
Secondary outcomes (1)
Modified behavioral scale, administered every 12 hours during the study, a standard neurobehavioral rating scale, some experimental tests of dominant frontal lobe function and a control task that we do not expect to be affected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2005 (estimated)
- Study start28 Jun 2005
- Study completion10 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117858
- Sponsor's protocol ID
- 050180
- Other IDs
- 05-N-0180
- Status last verified
- 10 May 2007
- First submitted
- 7 Jul 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
PubMed 15753425
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Trial of DC Polarization in FTD
- ClinicalTrials.gov ID
- NCT00117858
- Acronym / sponsor ID
- 050180
- Conditions
- Dementia
- Keywords
- Frontal Lobe, Language, Behavior, Degenerative Diseases, Pick's Disease, Frontotemporal Dementia, FTP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 28 Jun 2005
- Study completion
- 10 May 2007
- First posted
- 8 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is designed to test how direct current (DC) electrical polarization of the brain affects language and behavior in patients with frontotemporal dementia (FTD). FTD is the second most common form of dementia after Alzheimer's disease. It causes profound disturbances of language and other cognitive functions and often results in highly disruptive behavior. There is no effective treatment for the behavioral disorder or cognitive deficits in FTD. In an earlier study, the researchers used DC polarization to the primary motor cortex to enhance prefrontal function in healthy subjects. The experiment resulted in greater verbal fluency. In a separate study of five patients with FTD, a similar effect on verbal fluency was produced. The object of the current study is to replicate these findings in a larger group of patients and to see if the results carry over into "real world" behavior.
Participants will be 20 patients aged 35 to 75 years with FTD, referred to the Cognitive Neuroscience Section.
Participants will be tested in two sessions, separated by at least 48 hours. In one session they will receive 40 minutes of anodal DC polarization; in the other they will receive 40 minutes of sham polarization. Participants will be tested for language, memory, and reaction time before and 20 minutes after the polarization. For the behavior portion of the study, the Neuropsychiatric Inventory will be completed by an investigator with the caretaker on admission (covering the preceding week) and again, by telephone, 1 week after discharge, to cover the first week home.
Participants will receive no lasting benefit as a result of the study, but the study is likely to yield generalizable knowledge on the effects of DC polarization treatment in FTD.
Detailed description
Introduction: In a recent sham-controlled pilot study we showed that surface anodal DC polarization can improve verbal fluency in patients with frontotemporal dementia (FTD). This study is designed to extend those findings in a double blind trial. Objective: To see whether surface anodal DC polarization can improve verbal fluency and a global measure of behavior in FTD patients. Design: We propose to treat 20 FTD patients anodal and sham DC polarization in a double blind, crossover trial. Outcome Measures: The primary outcome measures are verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia. Secondary outcomes will include a modified behavioral scale, administered every 12 hours during the study, a standard neurobehavioral rating scale, some experimental tests of dominant frontal lobe function and a control task that we do not expect to be affected.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- meet diagnostic criteria for FTD (Knopman et al., 2005)
- be capable of understanding and cooperating with task instructions
- be fluent enough to generate at least three words in one category in one minute
- be between ages 35 to 75
- be right handed.
Key exclusion criteria (4 listed)
- Presence of metal (prostheses, electrodes, other medical hardware, shrapnel) in the cranial cavity
- Broken skin in the area of the electrodes
- Inability to comprehend the experiment or to cooperate with treatment or testing
- Any uncontrolled medical problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal DC polarization of left prefrontal cortex | Procedure or surgery | – |
Primary outcome
Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.
1 secondary outcome
Modified behavioral scale, administered every 12 hours during the study, a standard neurobehavioral rating scale, some experimental tests of dominant frontal lobe function and a control task that we do not expect to be affected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15753425Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anodal DC polarization of left prefrontal cortex in people with Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal fluency and the score on the Neuropsychiatric Index, a commonly used scale for behavioral problems in dementia.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.