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New treatment option for Mild Cognitive Impairment (MCI)
Official title Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
ClinicalTrials.gov ID: NCT07212504
What this study is testing
- What it's testing
- The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- 55 - 85 years of age (on the day of randomization)
- are male or post-menopausal female
- have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score \< 26 or where available, results from clinical...
- score 24 or higher on the Mini Mental State Examination (MMSE)
- are willing to provide informed consent
You likely can't join if
- have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are...
- have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
- have a cardiac pacemaker
- have an implanted medication pump
- have a central venous line
- have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or...
See the full eligibility criteria
- 55 - 85 years of age (on the day of randomization)
- are male or post-menopausal female
- have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score \< 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first...
- score 24 or higher on the Mini Mental State Examination (MMSE)
- are willing to provide informed consent
- are able to follow the treatment schedule
- are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications)
- have a satisfactory safety screening questionnaire for TMS
- have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe.
- have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
- have a cardiac pacemaker
- have an implanted medication pump
- have a central venous line
- have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
- have a history of substance abuse in the last 6 months
- have a history of stroke or other brain lesions
- have a personal history of epilepsy
- have a family history of epilepsy
- are a pregnant or breast-feeding woman
- have a history of abnormal MRI of the brain
- have untreated hypo- or hyper-thyroidism
- have unstable medical condition(s)
- have any other known contraindications to TMS
- are on unstable doses of any psychotropic medication such as antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
- regularly use benzodiazepines or other hypnotics within 2 weeks of randomization
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.