Pick Disease of the BrainPhase 1NCT00077896
Direct Current Brain Polarization in Frontotemporal Dementia
A Phase 1 study testing Direct Current Polarization in people with Pick Disease of the Brain, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pick Disease of the Brain
- What is being tested?
- Direct Current Polarization
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Aug 2005
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pick Disease of the Brain
- Being tested
- Direct Current Polarization
- Keywords
- Treatment, Transcranial Stimulation, Frontal Lobe, Pick's Disease, Cognitive Impairment, Dementia, Frontotemporal Dementia, FTD
- Medical subject headings
- Pick Disease of the Brain, Cognitive Dysfunction, Dementia, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Current PolarizationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2004 (estimated)
- Study startFeb 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pick Disease of the BrainStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077896
- Sponsor's protocol ID
- 040122
- Other IDs
- 04-N-0122
- Status last verified
- Aug 2005
- First submitted
- 12 Feb 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 3808255Antal 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.
PubMed 12698316Baudewig 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.
PubMed 11180425
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Current Brain Polarization in Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT00077896
- Acronym / sponsor ID
- 040122
- Conditions
- Pick Disease of the Brain
- Keywords
- Treatment, Transcranial Stimulation, Frontal Lobe, Pick's Disease, Cognitive Impairment, Dementia, Frontotemporal Dementia, FTD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 2004
- Study completion
- Aug 2005
- First posted
- 13 Feb 2004 (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 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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Direct Current Polarization | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3808255Agnew 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.
- Background: PubMed 12698316Antal 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.
- Background: PubMed 11180425Baudewig 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.
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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 1 study testing Direct Current Polarization in people with Pick Disease of the Brain, 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 1 inclusion and 5 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 4 Mar 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077896, which also lists 3 linked publications.
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 4 Mar 2008.