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OpenTrials
Completed

NCT Number: NCT03236454

tDCS-enhanced Working Memory Training in Subjective Cognitive Decline

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, 72074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DC-Stimulator MC, NeuroConn

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.

Primary outcomes

  1. Change in amount of worrying regarding the memory impairment

    Time frame: 4 weeks

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2020
First posted
Aug 2, 2017
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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