tDCS-enhanced Working Memory Training in Subjective Cognitive Decline
Effects and Mechanisms of Cognitive Control Training Combined With Transcranial Direct Current Stimulation (tDCS) in Subjective Cognitive Decline.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
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 11, 2017
CompletedFirst Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 13, 2020
January 1, 2020
5 months
July 27, 2017
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 weeks
Secondary Outcomes (5)
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.
4 weeks
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).
2 years
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).
2 years
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).
2 years
Group comparison (active vs. sham tDCS) regarding changes in the Neuropsychological Test Battery CERAD-Plus (pre-session outcomes compared with follow-up outcomes).
2 years
Study Arms (2)
anodal tDCS
ACTIVE COMPARATORDC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation
sham tDCS
SHAM COMPARATORDC-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;
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, 72074, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Plewnia, MD
University of Tübingen, Department of Psychiatry and Psychotherapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Sham Stimulation: Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Apl. Prof.
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 2, 2017
Study Start
May 11, 2017
Primary Completion
September 30, 2017
Study Completion
January 1, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01