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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03227185
Other study ID # 3351
Secondary ID 2016-02175
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date October 19, 2019

Study information

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

Clinical Trial Summary

Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) improved episodic memory performance, indicating a possible use as an intervention for patients suffering from memory impairments. At the same time, only scant evidence (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted application.

The present study aims at establishing a connection between the stimulation-induced change in episodic memory performance on the behavioural level and neurophysiological parameters. TDCS effects and the underlying mechanisms will be compared between different study conditions, receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal cortex during an episodic memory task.


Recruitment information / eligibility

Status Terminated
Enrollment 55
Est. completion date October 19, 2019
Est. primary completion date October 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

- Written informed consent

- Right-handedness

- Non-smokers

- 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

- Pregnancy

- Skin diseases

Study Design


Intervention

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

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
Primary Episodic memory performance - learning curve Number of encoded words during the three consecutive immediate retrievals in the encoding phase 0.25 hours
Primary Episodic memory performance - delayed recall 1 Number of remembered words in the delayed recall after a short delay at the day of the on-site visit 20 min after encoding phase
Primary Episodic memory performance - delayed recall 2 Number of remembered words one day after learning 1 day after on-site visit
Secondary Neurotransmitter levels Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC) 0.5 hours
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