Using brain stimulation to improve cognitive function and depression in older adults with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study aims to establish the dose-response curves for accelerated Transcranial Magnetic Stimulation (TMS) in patients aged 60-85 with Mild Cognitive Impairment (MCI) and comorbid depression. The study will manipulate the total number of active pulses delivered during TMS sessions to determine the optimal dosing for improving both cognitive function and depressive symptoms. Participants will receive either active TMS or a sham treatment, with the goal of informing future trials on the efficacy of this non-invasive brain stimulation technique. The findings will help develop effective treatments to prevent dementia in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

i. Age 60-85 (inclusive). ii. English as a first/primary language. iii. Adequate sensorimotor function and verbal expressive abilities to complete all assessments.

iv. Must have a Co-Participant (e.g. spouse, adult child or relative, sibling, cohabitator, friend, caregiver) who has at least weekly in-person contact with the participant and is willing to participate in the study as a collateral informant.

v. Is on fixed pharmacotherapy (i.e. a stable dose of medication/s) for at least 4 weeks prior to enrollment. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen for at least 4 weeks prior to enrollment. Prior treatment with anti-amyloid monoclonal antibody therapy is acceptable if last infusion was at least 8 weeks prior to enrollment. Prior TMS treatment is acceptable if last stimulation session was at least 24 weeks prior to enrollment.

vi. A documented diagnosis of MCI per NIA-AA criteria or Mild Neurocognitive Disorder per DSM-5 criteria by a healthcare provider within the past 2 years, with a presumed etiology of either (or both): vi.a Possible or probable AD vi.b Chronic cerebrovascular disease (CVD), specifically small vessel disease as defined in STRIVE-2 which includes small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, cerebral micro bleeds, cortical superficial siderosis, or cortical cerebral microinfarcts. .

vii. Met actuarial neuropsychological criteria for MCI within the past 2 years (i.e. ≥2 impaired scores within one cognitive domain, or ≥1 impaired scores in ≥3 domains, where an impaired score is defined as ≤16th percentile using appropriate demographically-corrected norms).

viii. Any lifetime depression, as defined by current or past Major Depressive Disorder per DSM-5.

Exclusion Criteria:

i. A TICS score of ≤ 19 suggestive of dementia. ii. Prior diagnosis of Dementia (NIA-AA) or Major Neurocognitive Disorder (DSM-5).

iii. Daily/weekly anticholinergic or sedative use. Stimulants may be allowed pending investigator review.

iv. History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury, seizures).

v. Current treatment for AD/MCI with monoclonal antibody therapy or plan to initiate treatment within three months of enrollment.

vi. Current use of any implanted brain stimulation device. vii. Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days.

viii. MRI contraindications (e.g., ferromagnetic implants, claustrophobia) ix. TMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking medications that have short half-lives, no identifiable motor threshold).

x. Current alcohol or substance use disorder, bipolar disorder, schizophrenia spectrum or other psychotic disorder, suicidal/homicidal intent within the past month, or any suicide attempts within the past year.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Andreana Benitez, PhD — Medical University of South Carolina
• Study coordinator: Andreana Benitez, PhD
• Email: benitez@musc.edu
• Phone: 843-876-2479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using psilocybin to treat depression in people with mild cognitive impairment or early Alzheimer's disease

  This study is testing if psilocybin can help improve mood and quality of life for people with mild cognitive impairment or early Alzheimer's disease who are feeling depressed.

  Recruiting Early Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT04123314

• Smartphone-supported single-session psychotherapy for postpartum depression

  A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07925762

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Remote monitoring for adults with depression using ThIA Suivi

  This study tests whether adding the ThIA Suivi remote monitoring tool to usual psychiatric care helps adults with depression feel more improved after 3 months compared with standard care alone.

  Recruiting at 3 sites Phase 1 ThIA Santé Mentale · Bron and 2 other locations · NCT07878754

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.