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Neural Correlates of Repeated tDCS

Primary Purpose

Mild Cognitive Impairment

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

active tDCS

sham tDCS

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring tDCS, Mild Cognitive Impairment, fMRI, Healthy ageing

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Maastricht UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

MCI-active

MCI-sham

Healthy Old-active

Healthy old-sham

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

neural changes after multi-session tDCS

fMRI-BOLD response

network changes after multi-session tDCS

functional connectivity between network hubs

Secondary Outcome Measures

Task performance changes after multi-session tDCS

BPS-score

Full Information

NCT ID

NCT02997007

First Posted

November 23, 2016

Last Updated

March 22, 2018

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02997007

Brief Title

Neural Correlates of Repeated tDCS

Official Title

Investigating the Neural Correlates of Repeated tDCS in MCI and Healthy Ageing With fMRI

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 2, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

tDCS, Mild Cognitive Impairment, fMRI, Healthy ageing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MCI-active

Arm Type

Experimental

Arm Description

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

Arm Title

MCI-sham

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Healthy Old-active

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy old-sham

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

active tDCS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

sham tDCS

Intervention Description

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

Primary Outcome Measure Information:

Title

neural changes after multi-session tDCS

Description

fMRI-BOLD response

Time Frame

5-12 days

Title

network changes after multi-session tDCS

Description

functional connectivity between network hubs

Time Frame

5-12 days

Secondary Outcome Measure Information:

Title

Task performance changes after multi-session tDCS

Description

BPS-score

Time Frame

5-12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa Müller-Ehrenberg, MSc

Phone

0031433881025

l.muller-ehrenberg@maastrichtuniversity.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Heidi IL Jacobs, PhD

Phone

0031433884090

h.jacobs@maastrichtuniversity.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heidi IL Jacobs, PhD

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Frans RJ Verhey, Professor

Organizational Affiliation

Maastricht University

Official's Role

Study Chair

Facility Information:

Facility Name

Maastricht University

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6221ET

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa Müller-Ehrenberg, MSc

Phone

0031433881025

l.muller-ehrenberg@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Neural Correlates of Repeated tDCS

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