Influence of tDCS on Cortical Plasticity in Healthy Older Adults

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01888055

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Older Adults	Device: transcranial direct current stimulation Device: sham stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Healthy Older Adults

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: transcranial direct current stimulation	Device: transcranial direct current stimulation
Placebo Comparator: sham stimulation	Device: sham stimulation

Arm

Intervention/Treatment

Experimental: transcranial direct current stimulation

Device: transcranial direct current stimulation

Placebo Comparator: sham stimulation

Device: sham stimulation

Outcome Measures

Primary Outcome Measures

anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults [1 week]
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

Secondary Outcome Measures

Comparison of tDCS-induced changes on central cholinergic activity [1 week]
to investigate weather anodal transcranial direct-current stimulation affect central cholinergic activity (measured via a TMS-protocol) in healthy older adults compared to sham stimulation
Comparison of tDCS-induced changes in the learning success [1 week]
tDCS-induced changes on learning success (performance in a motor learning paradigm in healthy older adults after tDCS vs. sham)
MR elastography [1 week]
Comparison of viscoelastic parameters in cerebral MR elastography in healthy older adults
genetic polymorphism, ApoE4 [once]
optional assessment of genetic Apo4 epsilon status for assessment of differences in cortical plasticity and elasticity between Apo4 epsilon positive and negative participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01888055

Other Study ID Numbers:

Plasticity in healthy adults

First Posted:

Jun 27, 2013

Last Update Posted:

May 14, 2021

Last Verified:

May 1, 2021

Keywords provided by Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

Healthy older adults Cortical Plasticity

Transcranial Direct Current Stimulation

Study Results

No Results Posted as of May 14, 2021