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New treatment option for Amnestic Mild Cognitive Impairment - aMCI
Official title Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment
ClinicalTrials.gov ID: NCT07643363
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy and safety of temporal interference stimulation (TIS), a non-invasive neuromodulation technique, in improving cognitive function in patients with cognitive impairment. TIS uses two high-frequency currents applied transcranially, which intersect within the brain to generate a low-frequency modulation field.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85
You may be able to join if
- meets the criteria for probable AD and MCI due to AD as defined by the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
- Positive amyloid biomarker (amyloid PET or CSF tTau/Aβ 42);
- Positive tau biomarker (tau-PET or CSF pTau181);
- AD-related standard treatments (acetyl cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists) taken at a stable dose for at least...
- meets the criteria for probable bvFTD as defined by the revised diagnostic criteria for the behavioural variant of frontotemporal dementia (2011), or...
You likely can't join if
- Diagnosis of other types of dementia or major neurological disorders (e.g., stroke, epilepsy, Lewy body dementia, vascular dementia, Parkinson's...
- Major psychiatric disorders such as severe depression or anxiety.
- Severe systemic or organ dysfunction (e.g., heart failure III-IV, liver cirrhosis, renal failure).
- Use of medications that significantly affect cognition (e.g., anticholinergics, sedatives), unless approved by the physician.
- Presence of metal implants incompatible with MRI or TIS (e.g., pacemakers, deep brain stimulators).
- Skull defects or cranial abnormalities.
See the full eligibility criteria
- meets the criteria for probable AD and MCI due to AD as defined by the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
- Positive amyloid biomarker (amyloid PET or CSF tTau/Aβ 42);
- Positive tau biomarker (tau-PET or CSF pTau181);
- AD-related standard treatments (acetyl cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists) taken at a stable dose for at least 12 weeks prior to baseline.
- meets the criteria for probable bvFTD as defined by the revised diagnostic criteria for the behavioural variant of frontotemporal dementia (2011), or PPA as defined by the Classification of primary progressive aphasia...
- Optional genetic confirmation of FTD-related pathogenic mutations (if available).
- Aged between 45 and 85 years, inclusive; no gender limitation.
- Right-handed.
- Education level ≥ 3 years.
- Mini-Mental State Examination (MMSE) score ≥ 11.
- Clinical Dementia Rating (CDR) score of 1 or 2.
- with a reliable caregiver
- Able to cooperate with cognitive assessments and cognitive training procedures.
- Full understanding of the study, voluntary participation, and provision of written informed consent approved by the Ethics Committee.
- Diagnosis of other types of dementia or major neurological disorders (e.g., stroke, epilepsy, Lewy body dementia, vascular dementia, Parkinson's disease dementia, Huntington's disease).
- Major psychiatric disorders such as severe depression or anxiety.
- Severe systemic or organ dysfunction (e.g., heart failure III-IV, liver cirrhosis, renal failure).
- Use of medications that significantly affect cognition (e.g., anticholinergics, sedatives), unless approved by the physician.
- Presence of metal implants incompatible with MRI or TIS (e.g., pacemakers, deep brain stimulators).
- Skull defects or cranial abnormalities.
- Inability to tolerate EEG or head stabilization.
- Severe visual or hearing impairment preventing task performance.
- History of alcohol or drug abuse.
- Participation in another clinical trial within the past 3 months.
- Current or recent treatment with anti-amyloid monoclonal antibodies (e.g., lecanemab, donanemab).
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
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, 45 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. 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.