Our objective is to use magnetic resonance imaging (MRI) to investigate the neural changes after repeated transcranial direct current stimulation during an episodic memory task in patients with mild cognitive impairment and in healthy age-matched…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measures are the Blood Oxygenation Level Dependent (BOLD)
reflecting brain activity during the functional task and functional
connectivity changes reflecting network integrity.
Secondary outcome
Secondary study parameters are performance on a pattern separation episodic
memory task (accuracy and reaction times). Performance on the task will be
correlated with BOLD-signal per session.
Background 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. 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 objective
Our objective is to use magnetic resonance imaging (MRI) to investigate the
neural changes after repeated transcranial direct current stimulation during an
episodic memory task in patients with mild cognitive impairment and in healthy
age-matched controls. A secondary objective is to investigate whether the
observed neural changes after stimulation correlate with behavioural changes on
an episodic memory task.
Study design
This is an experimental MRI study with a double-blind randomised design.
Intervention
Participants will receive either active tDCS or sham tDCS on five consecutive
days. Participants and the experimenter will be blind to the stimulation
condition. Participants are randomly assigned to a stimulation condition.
Study burden and risks
The expected risks and burden are expected to be minimal, since strict
inclusion and exclusion criteria for participation in the MRI and non-invasive
brain stimulation procedure are maintained. Participants will complete a
standard medical questionnaire that screens for contraindications. When
included, the burden and risks associated with this study involves the
participation in 7 sessions on 7 separate days, of which three sessions can be
carried out at the participant*s home (total duration: 10,5 hours). The first
day will start with the administration of several neuropsychological tests and
questionnaires (60 minutes) and a training session in a dummy scanner (30
minutes). On the second, sixth and seventh day, patients will be scanned in the
MRI scanner for 1 hour. MRI is a non-invasive method and the risks are
negligible (temporary dizziness in some individuals). On the third to fifth
day the participants will perform an episodic memory task at home or at the
university with concurrent active tDCS. TDCS is a safe and well tolerated
non-invasive brain stimulation method. No complications have been reported.
Some individuals report a tingling sensation on the skin where the electrodes
are placed, in rare cases skin irritation has been reported. The risks are thus
minimal.
Dr Tanslaan 12
Maastricht 6229ET
NL
Dr Tanslaan 12
Maastricht 6229ET
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57751.068.16 |