tDCS-enhanced Working Memory Training in Subjective Cognitive Decline

NCT ID: NCT03236454

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2020-01-01

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.

Conditions

Subjective Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

anodal tDCS

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

Group Type: ACTIVE_COMPARATOR

DC-Stimulator MC, NeuroConn

Intervention Type: DEVICE

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.

sham tDCS

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;

Group Type: SHAM_COMPARATOR

DC-Stimulator MC, NeuroConn

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Christian Plewnia, MD

Apl. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Plewnia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tübingen, Department of Psychiatry and Psychotherapy

Locations

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, , Germany

Countries

Germany

Other Identifiers

SCDStim-1

Identifier Type: -

Identifier Source: org_study_id