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tDCS-enhanced Working Memory Training in Subjective Cognitive Decline

Primary Purpose

Subjective Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DC-Stimulator MC, NeuroConn
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Cognitive Decline focused on measuring brain stimulation, cognitive training, cognition, treatment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men and women, aged 60 years and above Native German speaker Subjective feeling of worsening cognitive abilities, including memory Present concerns regarding the subjective memory decline Right handedness

Exclusion Criteria:

  • Present objective cognitive impairment (Mini-Mental State Examination < 24)
  • Current depression or depressive episode (Geriatric Depression Scale > 5)
  • Current substance abuse
  • Presence of other psychiatric disorders (MINI International Neuropsychiatric Interview)
  • History of epilepsy
  • Presence of other neurological disorders
  • Absence of independent living skills (Instrumental Activities Of Daily Living, IADL) Scale)
  • Metallic implants near the electrodes (i.e. pacemakers)

Sites / Locations

  • University of Tübingen, Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

anodal tDCS

sham tDCS

Arm Description

DC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation

DC-Stimulator MC, NeuroConn: 20 minutes of sham stimulation; Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end;

Outcomes

Primary Outcome Measures

Change in amount of worrying regarding the memory impairment
The amount of worrying regarding the memory impairment will be quantified by means of a 10-point Likert-Scale

Secondary Outcome Measures

Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the PASAT task from baseline to end of training period.
Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the verbal 2-back task (pre-session outcomes compared with post-session and follow-up outcomes).
Group comparison (active vs. sham tDCS) regarding changes in Trail Making Task A and B outcomes (pre-session outcomes compared with post-session and follow-up outcomes).
Group comparison (active vs. sham tDCS) regarding changes in Satisfaction With Life Scale outcomes (pre-session outcomes compared with post-session and follow-up outcomes).
Group comparison (active vs. sham tDCS) regarding changes in the Neuropsychological Test Battery CERAD-Plus (pre-session outcomes compared with follow-up outcomes).

Full Information

First Posted
July 27, 2017
Last Updated
January 9, 2020
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03236454
Brief Title
tDCS-enhanced Working Memory Training in Subjective Cognitive Decline
Official Title
Effects and Mechanisms of Cognitive Control Training Combined With Transcranial Direct Current Stimulation (tDCS) in Subjective Cognitive Decline.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This 2-armed randomized, sham-controlled, single-blind study aims at providing evidence for the efficacy of a transcranial direct current stimulation (tDCS)-enhanced cognitive control training (PASAT) in participants with subjective cognitive decline (SCD). Overall, the study will include 30 participants. Each participant will take part in a four weeks training (12 sessions); 50% of the participants will receive 2mA anodal tDCS for 20 minutes applied to the left dorsolateral prefrontal cortex (dlPFC), the other half will receive sham stimulation. Event-related potentials (ERPs) evoked by the feedback on the correctness of the response at baseline and after training will be measured with EEG as neurophysiological signatures of cognitive control. Near and far transfer will be assessed by a verbal 2-back task and the Trail Making Test A and B. The amount of worrying regarding the memory impairment will be quantified by means of a 10 point Likert-Scale. Together with changes of PASAT performance these measures will be obtained before and after the tDCS-enhanced training. Follow-up assessments 3, 12 and 24 months after training will investigate the stability of training effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline
Keywords
brain stimulation, cognitive training, cognition, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Sham Stimulation: Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS
Arm Type
Active Comparator
Arm Description
DC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
DC-Stimulator MC, NeuroConn: 20 minutes of sham stimulation; Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end;
Intervention Type
Device
Intervention Name(s)
DC-Stimulator MC, NeuroConn
Intervention Description
20 minutes of 2 mA anodal stimulation; Electrode placement: left dorsolateral prefrontal cortex (F3, EEG 10/20 system), return electrode at the right upper arm.
Primary Outcome Measure Information:
Title
Change in amount of worrying regarding the memory impairment
Description
The amount of worrying regarding the memory impairment will be quantified by means of a 10-point Likert-Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the PASAT task from baseline to end of training period.
Time Frame
4 weeks
Title
Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the verbal 2-back task (pre-session outcomes compared with post-session and follow-up outcomes).
Time Frame
2 years
Title
Group comparison (active vs. sham tDCS) regarding changes in Trail Making Task A and B outcomes (pre-session outcomes compared with post-session and follow-up outcomes).
Time Frame
2 years
Title
Group comparison (active vs. sham tDCS) regarding changes in Satisfaction With Life Scale outcomes (pre-session outcomes compared with post-session and follow-up outcomes).
Time Frame
2 years
Title
Group comparison (active vs. sham tDCS) regarding changes in the Neuropsychological Test Battery CERAD-Plus (pre-session outcomes compared with follow-up outcomes).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women, aged 60 years and above Native German speaker Subjective feeling of worsening cognitive abilities, including memory Present concerns regarding the subjective memory decline Right handedness Exclusion Criteria: Present objective cognitive impairment (Mini-Mental State Examination < 24) Current depression or depressive episode (Geriatric Depression Scale > 5) Current substance abuse Presence of other psychiatric disorders (MINI International Neuropsychiatric Interview) History of epilepsy Presence of other neurological disorders Absence of independent living skills (Instrumental Activities Of Daily Living, IADL) Scale) Metallic implants near the electrodes (i.e. pacemakers)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Plewnia, MD
Organizational Affiliation
University of Tübingen, Department of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tübingen, Department of Psychiatry and Psychotherapy
City
Tübingen
ZIP/Postal Code
72074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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tDCS-enhanced Working Memory Training in Subjective Cognitive Decline

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