Combining Speed of Processing Training with Brain Stimulation for Cognitive Improvement
Speed of Processing (SoP) Training Plus α-tACS in People With Mild Cognitive Impairment: a Double Blind, Parallel, Placebo Controlled Trial Study Protocol
NA · Portucalense University · NCT05198726
This study is testing if combining brain stimulation with a training program can help older adults with Mild Cognitive Impairment think faster and improve their memory and other thinking skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 327 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Portucalense University (other) |
| Locations | 1 site (Porto) |
| Trial ID | NCT05198726 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether Speed of Processing (SoP) training combined with alpha transcranial alternating current stimulation (α-tACS) can enhance cognitive processing speed in older adults with Mild Cognitive Impairment (MCI). Participants will undergo a double-blind, parallel randomized trial comparing the effects of active α-tACS versus sham stimulation alongside SoP training. The study will also investigate whether improvements in processing speed translate to enhancements in other cognitive areas such as memory, language, and executive functioning. Additionally, brain connectivity and coherence will be assessed using EEG to understand the underlying mechanisms of these interventions.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 65 and older experiencing cognitive decline in memory or other functions.
Not a fit: Patients with a diagnosis of Alzheimer's Disease or other serious medical conditions that may lead to further cognitive decline are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for patients with Mild Cognitive Impairment.
How similar studies have performed: While previous studies have shown modest effects of cognitive training and brain stimulation, this specific combination approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Community-dwelling adults aged 65 years and older, with cognitive complains in memory or other functions, which have declined over time Exclusion Criteria: * Score in the mini mental examination less than 23 (or over 28); * Diagnosis of Alzheimer´s Disease, any other medical condition that may predispose participants for a forthcoming decline in function, or that may increase their risk of mortality during the duration of the study. * Any contra-indication to tACS, severe sensory losses or communication difficulties that will prevent them from successfully complete the training. * Had any cognitive training in the past.
Where this trial is running
Porto
- Portucalense University — Porto, Portugal (RECRUITING)
Study contacts
- Principal investigator: Jorge Leite, PhD — Portucalense University
- Study coordinator: Jorge Leite, PhD
- Email: jorgel@upt.pt
- Phone: +351225572685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognitive Dysfunction, Mild Cognitive Impairment, tACS, Cognitive Training, MCI, Cognitive training