Multi-session 10 Hz transcranial alternating current stimulation to improve dual-task standing and brain activity in older adults with MCI
Multi-session Transcranial Alternating Current Stimulation to Improve Dual-task Standing and Brain Activity in Older Adults With Mild Cognitive Impairment
This trial will test whether repeated 10 Hz transcranial alternating current stimulation (tACS) over the front of the brain can boost alpha activity and improve dual-task standing and executive function in ambulatory adults aged 65–85 with mild cognitive impairment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | High Point University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (High Point, North Carolina) |
| Trial ID | NCT07097051 on ClinicalTrials.gov |
What this trial studies
This is a pilot, double-blinded, parallel-arm randomized trial comparing multi-session real 10 Hz tACS to sham stimulation in ambulatory older adults with mild cognitive impairment. Participants will undergo baseline and post-intervention EEG to measure alpha power, clinical tests of dual-task standing and balance, and neuropsychological measures of executive function. The intervention targets fronto-central alpha activity based on prior single-session findings that 10 Hz tACS can acutely increase alpha power and improve dual-task balance. Outcomes will determine whether repeated stimulation produces larger or more durable changes in brain activity and functional performance than sham.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 65–85 with mild cognitive impairment (CDR 0.5 and MoCA above the study cutoff, able to stand and walk independently) who can consent and comply with on-site visits.
Not a fit: People with more severe dementia than the study cutoffs, those unable to stand or walk independently, or those with contraindications to noninvasive brain stimulation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could improve balance during multitasking and support executive function, helping older adults with MCI maintain independence longer.
How similar studies have performed: Investigators have reported that a single session of 10 Hz tACS increased fronto-central alpha power and improved dual-task balance immediately afterward, but multi-session randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 65+ * Who have been diagnosed with cognitive impairment (based in MoCA or TICS and Clinical Dementia Rating: CDR 0.5) * Ability to stand and walk independently * Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained * Cut off of MOCA score \>18 will be applied * Able and willing to comply with all study requirements informed consent form was signed * Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator. Exclusion Criteria: * Cut off of MOCA score \<18 will be applied * Major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis * Blindness or other disabilities that prevent task performance * Self-reported history of stroke or neurodegenerative disorders other than MCI. * Self-reported active cancer for which chemo-/radiation therapy is being received. * Contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp.
Where this trial is running
High Point, North Carolina
- High Point University — High Point, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Melike Kahya
- Email: mkahya@highpoint.edu
- Phone: 3368419632
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.