Bipolar DisorderPhase 1NCT01339598
Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)
A Phase 1 study testing Transcranial direct current stimulation (Eldith DC Stimulator) in people with Bipolar Disorder, run by The University of New South Wales at 1 site in Australia.
Trial summary
This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Transcranial direct current stimulation (Eldith DC Stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2011to Oct 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be right-handed subjects aged 18-65 meeting DSM-IV diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks
- A score of ≤ 20 on the MADRS, and a score of ≤ 6 on the YMRS, who have been on a stable dose of mood stabiliser medications for at least 1 month.
Who cannot join
- Patients with high suicide risk
- Co-morbid DSM-IV diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder
- Mental retardation
- A history of drug or alcohol abuse or dependence within the last 3 months
- Co-morbid attention deficit hyperactivity disorder (ADHD), or any neurological disorder
- Recent stroke
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- Head injury
- History of seizure, or who have had electroconvulsive therapy (ECT) within the 6 months preceding enrolment.
- Participants will also be excluded if currently taking medications known to be associated with frank cognitive impairment (e.g., benzodiazepines).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.
- Conditions
- Bipolar Disorder
- Being tested
- Transcranial direct current stimulation (Eldith DC Stimulator)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (Eldith DC Stimulator)Device
Eldith DC Stimulator (NeuroConn GmbH, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Sham transcranial direct current stimulation | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation (Eldith DC Stimulator) |
| Transcranial direct current stimulation | Active comparator | Not described Receives: Device: Transcranial direct current stimulation (Eldith DC Stimulator) |
| Different transcranial direct current stimulation montage | Active comparator | Not described Receives: Device: Transcranial direct current stimulation (Eldith DC Stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total correct responses.
Total number of correct responses on each task in each session.
Measured: Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339598
- Sponsor's protocol ID
- HREC 11065
- Status last verified
- Jul 2015
- First submitted
- 7 Apr 2011
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT01339598
- Acronym / sponsor ID
- HREC 11065
- Conditions
- Bipolar Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Apr 2011 (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 study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham transcranial direct current stimulation | Sham comparator | Device: Transcranial direct current stimulation (Eldith DC Stimulator) |
| Transcranial direct current stimulation | Active comparator | Device: Transcranial direct current stimulation (Eldith DC Stimulator) |
| Different transcranial direct current stimulation montage | Active comparator | Device: Transcranial direct current stimulation (Eldith DC Stimulator) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be right-handed subjects aged 18-65 meeting DSM-IV diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks
- A score of ≤ 20 on the MADRS, and a score of ≤ 6 on the YMRS, who have been on a stable dose of mood stabiliser medications for at least 1 month.
Key exclusion criteria (9 listed)
- Patients with high suicide risk
- Co-morbid DSM-IV diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder
- Mental retardation
- A history of drug or alcohol abuse or dependence within the last 3 months
- Co-morbid attention deficit hyperactivity disorder (ADHD), or any neurological disorder
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 (Eldith DC Stimulator)Eldith DC Stimulator (NeuroConn GmbH, Germany) | Device | Different transcranial direct current stimulation montage, Sham transcranial direct current stimulation, Transcranial direct current stimulation |
Primary outcome
Total correct responses.
Time frame: Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.
Total number of correct responses on each task in each session.
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 3 Nov 2015.
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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 Transcranial direct current stimulation (Eldith DC Stimulator) in people with Bipolar Disorder, run by The University of New South Wales at 1 site in Australia.
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 2 inclusion and 9 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 3 Nov 2015. 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 Australia. 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.
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.
What does the primary outcome measure?
Total correct responses. (time frame: Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.). 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 3 Nov 2015.