Simultaneous tDCS and Computerised Gamified Short-term Memory Task Feasibility

NCT06402266 | Completed

• 1 other identifier: ACTTDCS
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to gain insight into the effects of transcranial direct current stimulation (tDCS) on short-term memory task performance and the feasibility of tDCS in overtly healthy carriers of the susceptibility allele, Apolipoprotein (APOE) ε4, for late-onset Alzheimers disease. The main questions the study aims to answer are:

• If tDCS is feasible in overtly healthy APOE ε4 carriers using a headset and an app-based short-term memory task.
• If overtly healthy APOE ε4 carriers perform better on a complex short-term memory task when receiving tDCS to the right hemisphere (F4 à PZ) compared to the left hemisphere (F3 à PZ) or sham tDCS. Participants will be asked to complete an app-based short-term memory task while receiving either tDCS to either the right or left hemisphere or sham stimulation on 3 different days spread out over 1-3 weeks.

Conditions

Genetic Predisposition

Keywords

Apolipoprotein E4; Cognitive reserve; Gamified cognitive training; Brain stimulation; tDCS; Technical compatibility

Outcome Measures

Primary Outcomes (3)

• Observations of the feasibility of simultaneous tDCS with a computerised, gamified short-term memory task

  The first outcome measure has to do with whether it is feasible to deliver tDCS via a portable headset while participants perform a computerised gamified STM task, in order to evaluate whether this would be possible in a home-based setting. This will be measured is by observing the sessions with this set-up and noting down difficulties during the session, including technical challenges and participant complaints.

  During stimulation (up to 1 hour)

• Participants' self-reported experience of the simultaneous tDCS with a computerised, gamified short-term memory task assessed by a self-report questionnaire

  The second outcome measure has to do with how the participants experienced the session. This will be assessed by having participants answer a self-report questionnaire on their experience after the session. The questionnaire consists of 3 overarching questions: 1) how the participants felt wearing the head-set; 2) how they experienced the stimulation, including whether they felt any discomfort; and 3) and how they experienced the overall set-up with the headset and the gamified STM task, including their assessment on whether they think it will work in a home-based setting.

  Post-stimulation (through study completion, up to 1 year)

• Effects of tDCS on computerised gamified short-term memory task performance

  The third outcome measure has to do with whether simultaneous brain stimulation affects participants' performance on the gamified STM task; or, more specifically, whether participants receiving tDCS stimulation performed better than those receiving sham stimulation. This is done by automatically logging the task data, which can then be accessed after the session. The outcome is evaluated as one overall score of STM performance based upon 1) identification accuracy, and 2) placement accuracy. A higher overall STM performance score indicates better performance.

  Post-stimulation (through study completion, up to 1 year)

Interventions

tDCS DEVICE

The STM task will be combined with respectively two times active tDCS and one sham tDCS. The 3 conditions will be randomised, and both scientific staff and participants will be blinded. Participants will perform the STM task on a tablet for 45 min. Headsets will deliver the tDCS. Two different placements will be used for the active stimulations: 1) F3 and PZ, and 2) F4 and PZ. The current output range will be 1.6mA and the stimulation will last for 30 min. The sham stimulation will function as a control condition. During the sham stimulation, the current density will be ramped up for 15 sec until the current reaches a density of 1.6mA for 60 sec and then again ramped down for 15 sec. After the session, participants will fill out a brief questionnaire regarding their experience. The time interval between sessions will be 1-3 weeks.

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy elderly APOE ε4 carriers recruited from an existing, in-house registry.

You may qualify if:

• Age range: 55-75 years old
• The participant is confirmed to carry at least one APOE ε4 allele on a blood test
• The participant has at least 7 years of education or a good working history
• Normal cognition (MMSE score \> 26)

You may not qualify if:

• Any dementia
• Significant systematic disease
• Severe and unstable medical disease or psychiatric disorder, including medications for these diseases or disorders
• Past history of stroke or brain damage
• Epilepsy or history of epileptic seizures
• Migraine
• Skin or scalp condition in the areas where the electrodes will be placed
• Depression
• Alcohol or drug abuse
• Significantly impaired vision or hearing
• Colour blindness
• Adverse effects to previous tDCS or other brain stimulation techniques

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Brain+ ApS: collaborator
• Eurostars EUREKA: collaborator
• Innovation Fund Denmark: collaborator

Study Sites (1)

Aarhus University, Centre for Functionally Integrative Neuroscience

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jakob U Blicher, Assoc. Prof.

  Aarhus University, Centre for Functionally Integrative Neuroscience (CFIN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: May 7, 2024
• Study Start: July 4, 2022
• Primary Completion: December 12, 2022
• Study Completion: November 23, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)