Mild Cognitive ImpairmentNCT02997007
Neural Correlates of Repeated tDCS
A study testing active tDCS in people with Mild Cognitive Impairment, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both associated with changes in brain network integrity. Episodic memory is especially affected in Alzheimer's disease, but is also decreased in healthy ageing. 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?
- active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 May 2017to Dec 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients
- Diagnosis of MCI based on the latest research criteria (clinical assessment at the memory clinic (prof. Frans RJ Verhey): presence of at least a memory impairment, memory complaints expressed by the patient or informant, no problems in daily life functioning, no dementia and presence of biomarkers (Albert et al., 2011)
- Clinical Dementia Rating score of 0.5 (CDR distinguishes a stage of questionable dementia (CDR 0.5) from people termed healthy (CDR 0) and those with mild dementia (CDR 1)
- Mini-Mental State Examination (MMSE) 23 and being mentally competent (in general, individuals with a MMSE 18 are considered mentally competent)
- Age: between 60 and 85 years old
- 50% female
Show all 16Show fewer
- Right-handedness
- Average level of education (CBS level 3-4-5-6)
- Healthy controls
- Average neuropsychological test results, in accordance with normative data, corrected for age, education and gender
- No substantial memory complaints (according to the participant)
- Age: between 60 and 85 years old
- 50% female
- Right-handedness
- Average level of education (CBS level 3-4-5-6)
- Normal or corrected to normal vision
Who cannot join
- Psychoactive medication use
- Abuse of alcohol and drugs
- Cognitive impairment due to alcohol/drug abuse or abuse of other substances
- Past or present psychiatric or neurological disorders (major depression, schizophrenia, bipolar disorder, psychotic disorder (or treatment for it), epilepsy, stroke, Parkinson's disease, multiple sclerosis, brain surgery, brain trauma, electroshock therapy, kidney dialysis, Menière's disease, brain infections)
- Major vascular disorders (e.g. stroke)
- Heart diseases or pacemakers
- Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, body tattoos)
- Large scars or fresh wounds on the scalp
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, Limburg, 6221ET
Lisa Müller-Ehrenberg, MSc, 0031433881025, l.muller-ehrenberg@maastrichtuniversity.nl
About this study
Official title: Investigating the Neural Correlates of Repeated tDCS in MCI and Healthy Ageing With fMRI
Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both associated with changes in brain network integrity. Episodic memory is especially affected in Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the memory-relevant brain networks are especially altered. Transcranial direct current stimulation (tDCS) has previously been implemented in different clinical- and non-clinical settings and has shown to beneficially influence network connectivity. The neural correlates of single-session tDCS have been investigated, however, the neural effects of repeated tDCS remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a treatment option in future studies.
- Conditions
- Mild Cognitive Impairment
- Being tested
- active tDCS, sham tDCS
- Keywords
- tDCS, Mild Cognitive Impairment, fMRI, Healthy ageing
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Participants will receive active tDCS over the angular gyrus on five consecutive days
sham tDCSDevice
Participants will receive sham tDCS over the angular gyrus on five consecutive days
| Study group | Role | What they receive |
|---|---|---|
| MCI-active | Experimental | Patients will receive verum tDCS over the angular gyrus on five consecutive days. Receives: Device: active tDCS |
| MCI-sham | Sham comparator | Patients will receive sham tDCS over the angular gyrus on five consecutive days. Receives: Device: sham tDCS |
| Healthy Old-active | Experimental | Participants will receive verum tDCS over the angular gyrus on five consecutive days. Receives: Device: active tDCS |
| Healthy old-sham | Sham comparator | Participants will receive sham tDCS over the angular gyrus on five consecutive days. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural changes after multi-session tDCS
fMRI-BOLD response
Measured: 5-12 days
network changes after multi-session tDCS
functional connectivity between network hubs
Measured: 5-12 days
Secondary outcomes (1)
Task performance changes after multi-session tDCS
BPS-score
Measured: 5-12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start2 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi IL Jacobs, PhD, Principal investigator, Maastricht UniversityFrans RJ Verhey, Professor, Study chair, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997007
- Sponsor's protocol ID
- NL57751.068.16
- Status last verified
- Mar 2018
- First submitted
- 23 Nov 2016
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Correlates of Repeated tDCS in MCI and Healthy Ageing With fMRI
- ClinicalTrials.gov ID
- NCT02997007
- Acronym / sponsor ID
- NL57751.068.16
- Conditions
- Mild Cognitive Impairment
- Keywords
- tDCS, Mild Cognitive Impairment, fMRI, Healthy ageing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Dec 2016 (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.
Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both associated with changes in brain network integrity. Episodic memory is especially affected in Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the memory-relevant brain networks are especially altered. Transcranial direct current stimulation (tDCS) has previously been implemented in different clinical- and non-clinical settings and has shown to beneficially influence network connectivity. The neural correlates of single-session tDCS have been investigated, however, the neural effects of repeated tDCS remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a treatment option in future studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MCI-active | Experimental | Device: active tDCSPatients will receive verum tDCS over the angular gyrus on five consecutive days. |
| MCI-sham | Sham comparator | Device: sham tDCSPatients will receive sham tDCS over the angular gyrus on five consecutive days. |
| Healthy Old-active | Experimental | Device: active tDCSParticipants will receive verum tDCS over the angular gyrus on five consecutive days. |
| Healthy old-sham | Sham comparator | Device: sham tDCSParticipants will receive sham tDCS over the angular gyrus on five consecutive days. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients
- Diagnosis of MCI based on the latest research criteria (clinical assessment at the memory clinic (prof. Frans RJ Verhey): presence of at least a memory impairment, memory complaints expressed by the patient or informant, no problems in daily life functioning, no dementia and presence of biomarkers (Albert et al., 2011)
- Clinical Dementia Rating score of 0.5 (CDR distinguishes a stage of questionable dementia (CDR 0.5) from people termed healthy (CDR 0) and those with mild dementia (CDR 1)
- Mini-Mental State Examination (MMSE) 23 and being mentally competent (in general, individuals with a MMSE 18 are considered mentally competent)
- Age: between 60 and 85 years old
Key exclusion criteria (8 listed)
- Psychoactive medication use
- Abuse of alcohol and drugs
- Cognitive impairment due to alcohol/drug abuse or abuse of other substances
- Past or present psychiatric or neurological disorders (major depression, schizophrenia, bipolar disorder, psychotic disorder (or treatment for it), epilepsy, stroke, Parkinson's disease, multiple sclerosis, brain surgery, brain trauma, electroshock therapy, kidney dialysis, Menière's disease, brain infections)
- Major vascular disorders (e.g. stroke)
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 |
|---|---|---|
| active tDCSParticipants will receive active tDCS over the angular gyrus on five consecutive days | Device | Healthy Old-active, MCI-active |
| sham tDCSParticipants will receive sham tDCS over the angular gyrus on five consecutive days | Device | Healthy old-sham, MCI-sham |
Primary outcome
neural changes after multi-session tDCS
Time frame: 5-12 days
fMRI-BOLD response
network changes after multi-session tDCS
Time frame: 5-12 days
functional connectivity between network hubs
1 secondary outcome
Task performance changes after multi-session tDCS
Time frame: 5-12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Heidi IL Jacobs, PhD principal investigator
Maastricht University
Frans RJ Verhey, Professor study chair
Maastricht 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 active tDCS in people with Mild Cognitive Impairment, run by Maastricht University Medical Center at 1 site in Netherlands.
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 16 inclusion and 8 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 26 Mar 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 Netherlands. 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 Lisa Müller-Ehrenberg, MSc (0031433881025, l.muller-ehrenberg@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neural changes after multi-session tDCS (time frame: 5-12 days). The study lists 2 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 26 Mar 2018.