Subjective Cognitive DeclineNCT03236454
tDCS-enhanced Working Memory Training in Subjective Cognitive Decline
A study testing DC-Stimulator MC, NeuroConn in people with Subjective Cognitive Decline, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- DC-Stimulator MC, NeuroConn
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2017to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, 72074
About this study
Official title: Effects and Mechanisms of Cognitive Control Training Combined With Transcranial Direct Current Stimulation (tDCS) 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.
- Conditions
- Subjective Cognitive Decline
- Being tested
- DC-Stimulator MC, NeuroConn
- Keywords
- brain stimulation, cognitive training, cognition, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-Stimulator MC, NeuroConnDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS | Active comparator | DC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation Receives: Device: DC-Stimulator MC, NeuroConn |
| sham tDCS | Sham comparator | 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; Receives: Device: DC-Stimulator MC, NeuroConn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start11 May 2017
- Primary completion30 Sep 2017
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Plewnia, MD, University Hospital Tuebingen
- Investigators
- Christian Plewnia, MD, Principal investigator, University of Tübingen, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236454
- Sponsor's protocol ID
- SCDStim-1
- Status last verified
- Jan 2020
- First submitted
- 27 Jul 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Cognitive Control Training Combined With Transcranial Direct Current Stimulation (tDCS) in Subjective Cognitive Decline.
- ClinicalTrials.gov ID
- NCT03236454
- Acronym / sponsor ID
- SCDStim-1
- Conditions
- Subjective Cognitive Decline
- Keywords
- brain stimulation, cognitive training, cognition, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS | Active comparator | Device: DC-Stimulator MC, NeuroConnDC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation |
| sham tDCS | Sham comparator | Device: DC-Stimulator MC, NeuroConnDC-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; |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC-Stimulator MC, NeuroConn20 minutes of 2 mA anodal stimulation; Electrode placement: left dorsolateral prefrontal cortex (F3, EEG 10/20 system), return electrode at the right upper arm. | Device | anodal tDCS, sham tDCS |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Plewnia, MD principal investigator
University of Tübingen, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC-Stimulator MC, NeuroConn in people with Subjective Cognitive Decline, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amount of worrying regarding the memory impairment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.