- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997007
Neural Correlates of Repeated tDCS
March 22, 2018 updated by: Maastricht University Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6221ET
- Recruiting
- Maastricht University
-
Contact:
- Lisa Müller-Ehrenberg, MSc
- Phone Number: 0031433881025
- Email: l.muller-ehrenberg@maastrichtuniversity.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MCI-active
Patients will receive verum tDCS over the angular gyrus on five consecutive days.
|
Participants will receive active tDCS over the angular gyrus on five consecutive days
|
Sham Comparator: MCI-sham
Patients will receive sham tDCS over the angular gyrus on five consecutive days.
|
Participants will receive sham tDCS over the angular gyrus on five consecutive days
|
Experimental: Healthy Old-active
Participants will receive verum tDCS over the angular gyrus on five consecutive days.
|
Participants will receive active tDCS over the angular gyrus on five consecutive days
|
Sham Comparator: Healthy old-sham
Participants will receive sham tDCS over the angular gyrus on five consecutive days.
|
Participants will receive sham tDCS over the angular gyrus on five consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neural changes after multi-session tDCS
Time Frame: 5-12 days
|
fMRI-BOLD response
|
5-12 days
|
network changes after multi-session tDCS
Time Frame: 5-12 days
|
functional connectivity between network hubs
|
5-12 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Task performance changes after multi-session tDCS
Time Frame: 5-12 days
|
BPS-score
|
5-12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heidi IL Jacobs, PhD, Maastricht University
- Study Chair: Frans RJ Verhey, Professor, Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2017
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
December 14, 2016
First Posted (Estimate)
December 19, 2016
Study Record Updates
Last Update Posted (Actual)
March 26, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL57751.068.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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