NCT01888055

Brief Summary

The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

4.4 years

First QC Date

June 25, 2013

Last Update Submit

May 12, 2021

Conditions

Keywords

Healthy older adults Cortical PlasticityTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults

    to investigate whether the anodal transcranial direct current stimulation over the primary motor cortex (M1) in healthy older adults increases cortical plasticity (measured via motor evoked potentials)compared to sham stimulation

    1 week

Secondary Outcomes (4)

  • Comparison of tDCS-induced changes on central cholinergic activity

    1 week

  • Comparison of tDCS-induced changes in the learning success

    1 week

  • MR elastography

    1 week

  • genetic polymorphism, ApoE4

    once

Study Arms (2)

transcranial direct current stimulation

EXPERIMENTAL
Device: transcranial direct current stimulation

sham stimulation

PLACEBO COMPARATOR
Device: sham stimulation

Interventions

transcranial direct current stimulation
sham stimulation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • right-handed according to the Oldfield Händigkeits inventory (lateralization index \>70)(1971)
  • no obvious cognitive impairment (MMSE\>26, Demtect\>13)
  • age between 50 and 80 years

You may not qualify if:

  • Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
  • Epilepsy, epileptic seizure in medical history
  • Cognitive deficit (MMSE \<20)
  • Depressive episode (Beck Depression Inventory (BDI) \> 12)
  • intake of centrally active drugs \<3 months , particularly acetylcholinesterase inhibitors
  • Pregnancy
  • Pacemaker (contraindication for MRI)
  • Other metal parts in the body (contraindication for MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations