Clinical trial NCT03236454: 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
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Decline
Keywords: brain stimulation
cognitive training
cognition
treatment
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in amount of worrying regarding the memory impairment
timeFrame: 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: 4 weeks
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: Group comparison (active vs. sham tDCS) regarding changes in the Neuropsychological Test Battery CERAD-Plus (pre-session outcomes compared with follow-up outcomes).
timeFrame: 2 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen, Department of Psychiatry and Psychotherapy
Study officials:
affiliation: University of Tübingen, Department of Psychiatry and Psychotherapy
name: Christian Plewnia, MD
role: PRINCIPAL_INVESTIGATOR
References: