Neural Correlates of Repeated tDCS

NCT02997007 | Unknown DMC

• 1 other identifier: NL57751.068.16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

tDCS; Mild Cognitive Impairment; fMRI; Healthy ageing

Outcome Measures

Primary Outcomes (2)

• neural changes after multi-session tDCS

  fMRI-BOLD response

  5-12 days

• network changes after multi-session tDCS

  functional connectivity between network hubs

  5-12 days

Secondary Outcomes (1)

• Task performance changes after multi-session tDCS

  5-12 days

Study Arms (4)

MCI-active

EXPERIMENTAL

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

Device: active tDCS

MCI-sham

SHAM COMPARATOR

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

Device: sham tDCS

Healthy Old-active

EXPERIMENTAL

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

Device: active tDCS

Healthy old-sham

SHAM COMPARATOR

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

Device: sham tDCS

Interventions

active tDCS DEVICE

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

Healthy Old-active; MCI-active

sham tDCS DEVICE

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

Healthy old-sham; MCI-sham

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % 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
• % female
• Right-handedness
• Average level of education (CBS level 3-4-5-6)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6221ET, Netherlands

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Heidi IL Jacobs, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Frans RJ Verhey, Professor

  Maastricht University

  STUDY CHAIR

Central Study Contacts

Lisa Müller-Ehrenberg, MSc

CONTACT

0031433881025; l.muller-ehrenberg@maastrichtuniversity.nl

Heidi IL Jacobs, PhD

CONTACT

0031433884090; h.jacobs@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 19, 2016
• Study Start: May 2, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

NL (1)