Neural Correlates of Repeated tDCS

NCT ID: NCT02997007

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MCI-active

Patients will receive verum tDCS over the angular gyrus on five consecutive days.

Group Type EXPERIMENTAL

active tDCS

Intervention Type DEVICE

Participants will receive active tDCS over the angular gyrus on five consecutive days

MCI-sham

Patients will receive sham tDCS over the angular gyrus on five consecutive days.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

Participants will receive sham tDCS over the angular gyrus on five consecutive days

Healthy Old-active

Participants will receive verum tDCS over the angular gyrus on five consecutive days.

Group Type EXPERIMENTAL

active tDCS

Intervention Type DEVICE

Participants will receive active tDCS over the angular gyrus on five consecutive days

Healthy old-sham

Participants will receive sham tDCS over the angular gyrus on five consecutive days.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

Participants will receive sham tDCS over the angular gyrus on five consecutive days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

active tDCS

Participants will receive active tDCS over the angular gyrus on five consecutive days

Intervention Type DEVICE

sham tDCS

Participants will receive sham tDCS over the angular gyrus on five consecutive days

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heidi IL Jacobs, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Frans RJ Verhey, Professor

Role: STUDY_CHAIR

Maastricht University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maastricht University

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lisa Müller-Ehrenberg, MSc

Role: CONTACT

0031433881025

Heidi IL Jacobs, PhD

Role: CONTACT

0031433884090

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lisa Müller-Ehrenberg, MSc

Role: primary

0031433881025

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL57751.068.16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Studying Motor Neuron Tests
NCT01517087 COMPLETED
Brain Encoding for Memory
NCT00051870 COMPLETED
Cerebral Blood Flow and tDCS
NCT04033133 COMPLETED NA