Mode
Text Size
Log in / Sign up
N/A Completed N=5 Treatment

Effect of Modulating Gamma Oscillations Using tACS

Source: ClinicalTrials.gov NCT03412604 ↗
Enrolled (actual)
5
Serious AEs
20.0%
Results posted
May 2021
Primary outcomePrimary: PET Amyloid Burden — -1.11 SUVR

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.

Outcome Measures

OutcomeResultp-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

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)
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

Back to search