Alzheimer DiseasetDCSNCT02518412
Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease
A study testing tDCS in people with Alzheimer Disease, run by University of Tromso at 1 site in Norway.
Trial summary
The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a cognitive enhancer for patients with Alzheimer disease. Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are applied to the brain by using two electrodes. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Feb 2016
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimers disease according to (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association).
- The cognitive impairment and decline must be documented by cognitive / neuropsychological testing and from an informant.
Who cannot join
- Stroke,
- Cancer,
- Psychiatric disorders (major depression, psychosis) or diseases / injuries in the central nervous system.
Trial locations and contacts
1 site in 1 country.
Per M Aslaksen, PhD contact
Martin K Bystad, Cand.psychol contact
Norway1 site, 1 recruiting
- Recruiting
Department of Psychology, University of Tromsø
Tromsø, N-9037
Per M Aslaksen, PhD, 004777649234
Martin K Bystad, Cand.Psychol, 004777620809
About this study
The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a cognitive enhancer for patients with Alzheimer disease.
Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are applied to the brain by using two electrodes. These electrodes are placed on the scalp. The current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the present study, participants will undergo six stimulations. The effect of all stimulations swill be measured with neuropsychological testing before the first (pre) and after the sixth tDCS stimulation (post).
Read the detailed description
The present study is a randomized controlled study (RCT) and will use tDCS to stimulate left temporal lobe and hopefully improve verbal memory functions. A total of 30 patients with Alzheimer disease will receive tDCS treatment for 30 minutes, six times. Half of the patients will undergo sham stimulation. These six stimulations will be executed during 10 days. Patients will be tested with neuropsychological tests before the first stimulation and after the last stimulation to assess the effect of the treatment. Patients will be retested six months later in order to investigate long-term effects ot the stimulation. The main hypothesis in the present study is that tDCS stimulation will lead to significant improvements in verbal memory functions.
- Conditions
- Alzheimer Disease
- Being tested
- tDCS, Placebo tDCS
- Keywords
- Alzheimers disease, Transcranial direct current stimulation (tDCS), Neuromodulation, Neuropsychology
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
Transcranial Direct Current Stimulation (tDCS) is a non-invasive treatment method, using a low Direct current stimulation to increase excitability and thus stimulate plasticity and cognitive functions.
Placebo tDCSOther
Half of the patients will receive Placebo tDCS. The procedure is the same as for active tDCS, but the in the Placebo tDCS the stimulation is non-active / sham.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants receive active tDCS stimulation. Half of the participants receive active tDCS stimulation, i.e 30 minutes active stimulation of the temporal cortex. Receives: Other: tDCS |
| Placebo tDCS | Placebo comparator | Participants receive placebo tDCS stimulation. Half of the participants receive placebo tDCS stimulation, i.e 30 minutes inactive stimulation of the temporal cortex. Receives: Other: Placebo tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological testing
We will use a neuropsychological test called California Verbal Learning Test and test verbal memory functions before the first treatment session and after the last treatment session. We will use this test to assess how the tDCS intervention will affect verbal memory functions. There will be a maximum of ten days between pre and post testing, since the entire stimulation procedure (six stimulations) will be executed during ten days.
Measured: Changes in results from neuropsychological testing pre (before the first stimulation) og post treatment (after the last stimulation). There will be a ten days time frame from pre-test to post-test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startMay 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
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 Alzheimer DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per M Aslaksen, PhD, Study director, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518412
- Sponsor's protocol ID
- 2012/1890(REK)
- Acronym
- tDCS
- Status last verified
- Aug 2015
- First submitted
- 8 Jun 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bystad M, Gronli O, Rasmussen ID, Gundersen N, Nordvang L, Wang-Iversen H, Aslaksen PM. Transcranial direct current stimulation as a memory enhancer in patients with Alzheimer's disease: a randomized, placebo-controlled trial. Alzheimers Res Ther. 2016 Mar 23;8(1):13. doi: 10.1186/s13195-016-0180-3.
PubMed 27005937
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease
- ClinicalTrials.gov ID
- NCT02518412
- Acronym / sponsor ID
- tDCS / 2012/1890(REK)
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimers disease, Transcranial direct current stimulation (tDCS), Neuromodulation, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 7 Aug 2015 (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 purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a cognitive enhancer for patients with Alzheimer disease.
Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are applied to the brain by using two electrodes. These electrodes are placed on the scalp. The current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the present study, participants will undergo six stimulations. The effect of all stimulations swill be measured with neuropsychological testing before the first (pre) and after the sixth tDCS stimulation (post).
Detailed description
The present study is a randomized controlled study (RCT) and will use tDCS to stimulate left temporal lobe and hopefully improve verbal memory functions. A total of 30 patients with Alzheimer disease will receive tDCS treatment for 30 minutes, six times. Half of the patients will undergo sham stimulation. These six stimulations will be executed during 10 days. Patients will be tested with neuropsychological tests before the first stimulation and after the last stimulation to assess the effect of the treatment. Patients will be retested six months later in order to investigate long-term effects ot the stimulation. The main hypothesis in the present study is that tDCS stimulation will lead to significant improvements in verbal memory functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Other: tDCSParticipants receive active tDCS stimulation. Half of the participants receive active tDCS stimulation, i.e 30 minutes active stimulation of the temporal cortex. |
| Placebo tDCS | Placebo comparator | Other: Placebo tDCSParticipants receive placebo tDCS stimulation. Half of the participants receive placebo tDCS stimulation, i.e 30 minutes inactive stimulation of the temporal cortex. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Alzheimers disease according to (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association).
- The cognitive impairment and decline must be documented by cognitive / neuropsychological testing and from an informant.
Key exclusion criteria (3 listed)
- Stroke,
- Cancer,
- Psychiatric disorders (major depression, psychosis) or diseases / injuries in the central nervous system.
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 |
|---|---|---|
| tDCSTranscranial Direct Current Stimulation (tDCS) is a non-invasive treatment method, using a low Direct current stimulation to increase excitability and thus stimulate plasticity and cognitive functions. | Other | Active tDCS |
| Placebo tDCSHalf of the patients will receive Placebo tDCS. The procedure is the same as for active tDCS, but the in the Placebo tDCS the stimulation is non-active / sham. | Other | Placebo tDCS |
Primary outcome
Neuropsychological testing
Time frame: Changes in results from neuropsychological testing pre (before the first stimulation) og post treatment (after the last stimulation). There will be a ten days time frame from pre-test to post-test.
We will use a neuropsychological test called California Verbal Learning Test and test verbal memory functions before the first treatment session and after the last treatment session. We will use this test to assess how the tDCS intervention will affect verbal memory functions. There will be a maximum of ten days between pre and post testing, since the entire stimulation procedure (six stimulations) will be executed during ten days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
- Derived from this study: PubMed 27005937Bystad M, Gronli O, Rasmussen ID, Gundersen N, Nordvang L, Wang-Iversen H, Aslaksen PM. Transcranial direct current stimulation as a memory enhancer in patients with Alzheimer's disease: a randomized, placebo-controlled trial. Alzheimers Res Ther. 2016 Mar 23;8(1):13. doi: 10.1186/s13195-016-0180-3.
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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.
Per M Aslaksen, PhD contact
Martin K Bystad, Cand.psychol contact
Per M Aslaksen, PhD study director
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Alzheimer Disease, run by University of Tromso at 1 site in Norway.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per M Aslaksen, PhD (0047776 49234), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological testing (time frame: Changes in results from neuropsychological testing pre (before the first stimulation) og post treatment (after the last stimulation). There will be a ten days time frame from pre-test to post-test.). 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 NCT02518412, 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 11 Aug 2015.