tDCS-enhanced Working Memory Training in Subjective Cognitive Decline

Subjective Cognitive Decline Clinical Trial

Official title:

Effects and Mechanisms of Cognitive Control Training Combined With Transcranial Direct Current Stimulation (tDCS) in Subjective Cognitive Decline.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236454
• Other study ID #: SCDStim-1
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Decline

Intervention

Device:
• DC-Stimulator MC, NeuroConn
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.

Locations

Country	Name	City	State
Germany	University of Tübingen, Department of Psychiatry and Psychotherapy	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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