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Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment
Condition(s) studied
Amnestic Mild Cognitive Impairment - aMCIAD-MCIAD - Alzheimer's DiseaseFTD
Investigational drug(s) / intervention(s)
Temporal Interference StimulationSham Temporal Interference StimulationTargeted Cognitive TrainingGeneral Cognitive Training
Temporal Interference Stimulation: Temporal interference stimulation will be delivered using two high-frequency alternating currents at 2000 Hz and 2100 Hz, generating a low-frequency envelope. Stimulation will be delivered in a theta-burst-like pattern with 2 seconds on and 8 seconds off. Frontal and temporal targets will be stimulated sequentially.
In the sham-controlled group, participants will receive active stimulation during Days 6-10 following 5 days of sham stimulation. In the active stimulation groups, participants will receive active stimulation throughout the entire 10-day intervention period. Two sessions will be administered per day, with each session lasting 40 minutes.
Sham Temporal Interference Stimulation: Sham stimulation will use two identical high-frequency currents of 2000 Hz and 2000 Hz, producing no frequency difference and no modulation envelope. The stimulation timing, electrode placement, and procedures will be consistent with active stimulation to maintain blinding. In the sham-controlled group, sham stimulation will be administered during Days 1-5 before switching to active stimulation.
Targeted Cognitive Training: Participants will complete structured cognitive training tasks designed to engage specific cognitive processes associated with the study objectives.
General Cognitive Training: Participants will complete general cognitive training tasks involving multiple cognitive domains without specifically emphasizing the primary targeted cognitive process.
Study summary
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. This technique selectively modulates deep brain regions while minimizing the stimulation of superficial cortical layers.
Participants will undergo individualized MRI-based modeling to determine the optimal electrode placement and stimulation parameters. The intervention consists of 10 stimulation sessions over a period of 14 days, using either active TIS or sham stimulation. Cognitive assessments, EEG recordings, and functional MRI scans will be conducted at baseline; 5 days after intervention initiation; at the end of the 10-day intervention; and during follow-up assessments at 4 weeks, 8 weeks, and 12 weeks post-intervention to evaluate both immediate and long-term effects on cognitive performance and neural activity.
The study aims to determine whether TIS can serve as a feasible and effective neuromodulation strategy for individuals with cognitive impairment.
Eligibility
Inclusion 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 and its variants (2011);
* 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.
Exclusion Criteria:
* 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).
Primary outcome measure(s)
- Changes from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score — Baseline; 5 days after intervention initiation; end of the 10-day intervention; and follow-up assessments at 4 weeks, 8 weeks, and 12 weeks post-intervention.
Measures global cognitive function. The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a clinician-administered scale commonly used to assess cognitive performance in individuals with cognitive impairment and dementia.
Full Scale Name: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
Typical Total Score Range: 0 to 70. Higher Scores Mean: Greater cognitive impairment (worse cognitive performance).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tianjin Huanhu Hospital |
Tianjin |
Tianjin Municipality |
Recruiting |
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