N/A
N=5
Effect of Modulating Gamma Oscillations Using tACS
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03412604 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
May 2021
Primary outcome: Primary: PET Amyloid Burden — -1.11 SUVR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Alternating Current Stimulation (tACS) (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PET Amyloid Burden |
-1.11 | — |
| PRIMARY PET Tau Deposition |
-2.85 | — |
| SECONDARY PET Microglia Activation |
-0.56 | — |
| SECONDARY Changes in Brain Perfusion as Measured by Arterial Spin Labeling |
1.2 | — |
Summary
This study aims to implement an intervention based on multiple, individualized multifocal tACS stimulation sessions based on individual PET and MRI information in patients with amyloid-positive PET with the hope that this leads to microglia activation and decrease in cerebral amyloid and tau depositions in human patients with AD.
Eligibility Criteria
Inclusion Criteria
- Clinical Diagnosis of mild to moderate AD*
- Mini Mental State Examination (MMSE) > 18
- Mild AD ≥ 21
- Moderate AD 18-20
- Demonstration or history of memory impairments.
- Confirmation of diagnosis will be made by the study MD based on a holistic consideration of the participant's cognitive evaluation and history.
- Amyloid positive PET imaging
- At least 45 years old
- On a stable dose of medications for memory loss including cholinesterase inhibitors (e.g. donepezil, rivastigmine or memantine) as defined as 6 consecutive weeks of treatment at an unchanging dose
- Minimum of completed 8th grade education
- IQ> 85 as determined by the WTAR and no history of intellectual disability
Exclusion Criteria
- Current history of poorly controlled migraines including chronic medication for migraine prevention
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
- Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition.
- Contraindication for undergoing MRI or receiving TMS or tACS,
- >50 mSv of radiation exposure for research within the past year (PET imaging exclusion)
- Presence of the Thr/Thr polymorphism in the TSPO gene (rs6971) due to low affinity binding for the PBR 28 (microlgia) PET scan
- History of fainting spells of unknown or undetermined etiology that might constitute seizures.
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or immediate (1st degree relative) family history of epilepsy; with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator.
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
- Metal implants (excluding dental fillings) or devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt, cochlear implant, unless cleared by the study MD.
- Substance abuse or dependence within the past six months.
- Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of CNS active drugs.
- All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study.
- Subjects who, in the investigator's opinion, might not be suitable for the study
- A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig)
Data sourced from ClinicalTrials.gov (NCT03412604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.