NCT02587338

Brief Summary

This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tDCS\]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or sham tDCS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

June 16, 2015

Results QC Date

August 31, 2022

Last Update Submit

March 11, 2024

Conditions

Keywords

Subjective Memory ImpairmenttDCSNIRSCognitive TrainingWorking Memory

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT)

    The Investigators are measuring cognitive performance for different executive functions, here the score (percentile of the norm values) of the test verbal learning memory test (VLMT), parameter immediate recall post treatment is reported. Rage from 0 to 100 %. Higher values indicate higher performance.

    4 weeks

Secondary Outcomes (1)

  • Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT)

    4 weeks

Study Arms (2)

Verum tDCS

EXPERIMENTAL

Left frontal anodal stimulation, supraorbital right cathodal stimulation

Device: Verum tDCS

Sham tDCS

EXPERIMENTAL

sham stimulation, same electrode positions

Device: Sham tDCS

Interventions

Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anodal, right cathodal

Verum tDCS
Sham tDCSDEVICE

Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere

Sham tDCS

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • native german speaker
  • between 60-70 years old
  • subjective memory impairment

You may not qualify if:

  • psychiatric, neurological diseases
  • uncorrected hearing or vision deficits
  • actual psychopharmaco intake
  • metal parts in the head
  • medical electronical implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Prof. Dr. Martin Herrmann
Organization
Universitätsklinikum Würzburg

Study Officials

  • Martin J. Herrmann, PD Dr

    University of Würzburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

October 27, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2024-03

Locations