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New treatment option for Cognitive Dysfunction
Official title Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT04558164
What this study is testing
- What it's testing
- The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory.
- This is a blinded study.
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 100
You may be able to join if
- Agreement to participate in the study
- 55-100 years of age
- Right-handedness
- In good general health
- Living independently
You likely can't join if
- Unwilling or unable to provide informed consent
- Diagnosis of dementia
- Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment
- History of alcohol or substance abuse
- Recent (\< 6 months) alcohol or substance abuse (excluding nicotine or caffeine)
- History of stroke (if the stroke in our judgment is related to the memory problem), traumatic brain injury with loss of consciousness, or other...
See the full eligibility criteria
- Agreement to participate in the study
- 55-100 years of age
- Right-handedness
- In good general health
- Living independently
- Subjective memory complaints (self-report and positive score on MFQ)
- Katz ADL scale and Lawton iADL scale: We will review scores on a case-by-case basis if they did not score 100%. We will exclude if the scores show impairment in ADLs that suggests problems with independent functioning...
- MMSE score \> 24
- PHQ Depression score =\< 7
- Ability to read, write, and speak English fluently
- Diagnosis of mild neurocognitive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria. Participants with subjective memory complaints without an aMCI diagnosis will be reviewed on...
- No change in use of psychotropic medication for treatment of depression, anxiety, ADHS or psychosis 1 month prior and during the study. Screening diagnostic criteria for aMCI will be subjective memory complaints, intact...
- Unwilling or unable to provide informed consent
- Diagnosis of dementia
- Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment
- History of alcohol or substance abuse
- Recent (\< 6 months) alcohol or substance abuse (excluding nicotine or caffeine)
- History of stroke (if the stroke in our judgment is related to the memory problem), traumatic brain injury with loss of consciousness, or other neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's...
- Non-English speaking participants
- Not right handed based on self-report or evaluation based on a standard report
- Has received TMS before (not TMS naïve)
- Poorly controlled hypertension or cardiovascular disease
- Current enrollment in a memory-enhancement study or course
- Contraindication to TMS or MRI including claustrophobia, metal in body, surgery within 60 days, certain implants, or previous abnormal MRI results.
- scanning facial tattoos is okay if safe with MRI
- is taking:
- anticholinergic medication (e.g., Detrol, Cogentin);
- sedating antihistamine (e.g., Benadryl);
- any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, Remeron).
- benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis depending on the dose.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
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 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. 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.