Brain Damage, ChronicNCT01602276
The Effect of tDCS on Subcortical Brain Functioning
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Brain Damage, Chronic, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Damage, Chronic
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 10 Oct 2018
- Phase
- Interventional
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in the English language
- History of subcortical brain damage (patient group only)
- No known neurological or cognitive impairment (control group only)
Who cannot join
- Appreciable deficits in hearing
- Schizophrenia, bipolar disorder, or major depression (normal controls only)
- Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only)
- Language-based learning disorder (normal controls only)
- Dementia or Mini-Mental State Exam <24 for normal control participants
- Any implanted metal device (precludes use of tDCS)
- Any implanted cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology; Cognitive Neurology/Neuropsychology
Baltimore, Maryland, 21231
About this study
Official title: The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.
Read the detailed description
While cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. A significant fraction of the population suffer from disabling disorders and diseases (i.e., Parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. Despite their prevalence, very little success has been achieved in treating such impairments effectively.
This study has two main goals. One is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). A second goal is to examine the effects of varying some of the stimulus parameters of tDCS, notably the placement of the electrodes and the duration and frequency of application of current.
Adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. These tasks will be specific to the deficit of interest.
- Conditions
- Brain Damage, Chronic
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Parkinson's disease, Lewy body dementia, Korsakoff's syndrome, Subcortical Dementia, Huntington's Disease
- Medical subject headings
- Brain Damage, Chronic, Parkinson Disease, Lewy Body Disease, Korsakoff Syndrome, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Procedure or surgery
Anodal, Cathodal or Sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest Receives: Procedure: Transcranial Direct Current Stimulation (tDCS) |
| Sham Stimulation | Sham comparator | Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Receives: Procedure: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in motor functioning
Measured: 1 month
Improvement in level of consciousness and alertness
Measured: 1 month
Improvement in cognitive functioning
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startFeb 2012
- Primary completion9 Oct 2018
- Study completion10 Oct 2018
Why it stopped: Difficulty identifying appropriate patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Damage, ChronicStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry Gordon, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602276
- Sponsor's protocol ID
- NA_00047863
- Status last verified
- Dec 2018
- First submitted
- 14 May 2012
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning
- ClinicalTrials.gov ID
- NCT01602276
- Acronym / sponsor ID
- NA_00047863
- Conditions
- Brain Damage, Chronic
- Keywords
- Parkinson's disease, Lewy body dementia, Korsakoff's syndrome, Subcortical Dementia, Huntington's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty identifying appropriate patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 18 May 2012 (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 research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.
Detailed description
While cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. A significant fraction of the population suffer from disabling disorders and diseases (i.e., Parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. Despite their prevalence, very little success has been achieved in treating such impairments effectively.
This study has two main goals. One is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). A second goal is to examine the effects of varying some of the stimulus parameters of tDCS, notably the placement of the electrodes and the duration and frequency of application of current.
Adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. These tasks will be specific to the deficit of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Procedure: Transcranial Direct Current Stimulation (tDCS)Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest |
| Sham Stimulation | Sham comparator | Procedure: Transcranial Direct Current Stimulation (tDCS)Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent in the English language
- History of subcortical brain damage (patient group only)
- No known neurological or cognitive impairment (control group only)
Key exclusion criteria (7 listed)
- Appreciable deficits in hearing
- Schizophrenia, bipolar disorder, or major depression (normal controls only)
- Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only)
- Language-based learning disorder (normal controls only)
- Dementia or Mini-Mental State Exam <24 for normal control participants
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Anodal, Cathodal or Sham tDCS | Procedure or surgery | Active Stimulation, Sham Stimulation |
Primary outcome
Improvement in motor functioning
Time frame: 1 month
Improvement in level of consciousness and alertness
Time frame: 1 month
Improvement in cognitive functioning
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Difficulty identifying appropriate patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
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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.
Barry Gordon, M.D., Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Brain Damage, Chronic, run by Johns Hopkins University 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Dec 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty identifying appropriate patients). Results are not available in the source record.
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?
Improvement in motor functioning (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2018.