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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03351452
Other study ID # 2017-01197
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date February 24, 2020

Study information

Verified date March 2020
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore, tES methods might be a useful intervention tool for patients suffering from memory impairment in early terms of the disease.

The present study aims at establishing a connection between the stimulation-induced changes on associative memory performance and its underlying neurophysiological parameters. tES effects and their underlying mechanisms will be compared between healthy elderly controls and clinical study populations receiving either real or sham tES over the left ventrolateral prefrontal cortex during an associative memory task.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 24, 2020
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria:

- Written informed consent

- Non-smokers

- Right-handedness

- Native German speakers or comparable level of fluency

- Normal or corrected-to-normal vision

Exclusion Criteria:

- Neurological or psychiatric condition (other than diagnosed cognitive impairment)

- Past head injuries

- Magnetizable implants

- History of seizures

- Current or life-time alcohol or drug abuse

- Skin diseases

Study Design


Intervention

Device:
real anodal transcranial direct current stimulation
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
real transcranial alternating current stimulation
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
sham transcranial electric current stimulation
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.

Locations

Country Name City State
Switzerland University Hospital of Old Age Psychiatry and Psychotherapy Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Performance on cued recall task Number of correct responses on retrieval task of previously learned associative memory items follow-up after 24 hours
Other Performance on recognition task Number of correct responses on retrieval task of previously learned associative memory items follow-up after 24 hours
Primary Performance on immediate cued recall task Number of correct responses on retrieval task of previously learned associative memory items 20 min
Primary Performance on delayed cued recall task Number of correct responses on retrieval task of previously learned associative memory items 24 hours
Secondary task-dependent BOLD activity Measured with functional magnetic resonance imaging (fMRI) 20 min
Secondary resting-state BOLD activity Measured with functional magnetic resonance imaging (fMRI) 10 min
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