Mild Cognitive ImpairmentPhase 1/2NCT01653431
Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
A Phase 1/2 study testing Transcranial direct current stimulation in people with Mild Cognitive Impairment, run by The University of New South Wales at 1 site in Australia.
Trial summary
The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2013to 1 Nov 2019
- Phase
- Phase 1/2
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 - 85 years.
- Meet diagnostic criteria for amnestic mild cognitive impairment.
Who cannot join
- Inability to provide informed consent.
- Concurrent medication likely to affect mental performance.
- Current substance use or dependence in last 3 months.
- Current active psychiatric or neurological condition
Trial locations and contacts
1 site in 1 country.
About this study
The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Transcranial direct current stimulation combined with cognitive training Receives: Device: Transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Sham transcranial direct current stimulation combined with cognitive training Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test II
Measured: Post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2018
- Study completion1 Nov 2019
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 Mild Cognitive ImpairmentStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Pigot, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653431
- Sponsor's protocol ID
- HC12381
- Status last verified
- Feb 2020
- First submitted
- 30 Jul 2012
- Last updated
- 7 Feb 2020
- Results posted
- No
Publications
Martin DM, Mohan A, Alonzo A, Gates N, Gbadeyan O, Meinzer M, Sachdev P, Brodaty H, Loo C. A Pilot Double-Blind Randomized Controlled Trial of Cognitive Training Combined with Transcranial Direct Current Stimulation for Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2019 Aug 12;71(2):503-512. doi: 10.3233/JAD-190306.
PubMed 31424410
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01653431
- Acronym / sponsor ID
- HC12381
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 31 Jul 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.
The study will examine whether the effects of computerized brain training are enhanced when training is combined with mild brain stimulation in patients with mild cognitive impairment. We hypothesize that this combination will produce greater improvements in cognitive functioning than computerized brain training alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulationTranscranial direct current stimulation combined with cognitive training |
| Sham transcranial direct current stimulation | Sham comparator | Device: Transcranial direct current stimulationSham transcranial direct current stimulation combined with cognitive training |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 60 - 85 years.
- Meet diagnostic criteria for amnestic mild cognitive impairment.
Key exclusion criteria (4 listed)
- Inability to provide informed consent.
- Concurrent medication likely to affect mental performance.
- Current substance use or dependence in last 3 months.
- Current active psychiatric or neurological condition
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 | Device | Sham transcranial direct current stimulation, Transcranial direct current stimulation |
Primary outcome
California Verbal Learning Test II
Time frame: Post treatment
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 7 Feb 2020.
- Derived from this study: PubMed 31424410Martin DM, Mohan A, Alonzo A, Gates N, Gbadeyan O, Meinzer M, Sachdev P, Brodaty H, Loo C. A Pilot Double-Blind Randomized Controlled Trial of Cognitive Training Combined with Transcranial Direct Current Stimulation for Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2019 Aug 12;71(2):503-512. doi: 10.3233/JAD-190306.
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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 1/2 study testing Transcranial direct current stimulation in people with Mild Cognitive Impairment, 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 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 7 Feb 2020. 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 combined 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.
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?
California Verbal Learning Test II (time frame: Post treatment). 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 NCT01653431, 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 7 Feb 2020.