Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease (TRANSFORM-AD)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The goal of this study is to explore the efficacy and safety of transcranial alternating
      current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will
      recruit 40 individuals with mild AD with evidence of amyloid plaques in the brain through
      Positron Emission Tomography (PET) imaging. Participants will undergo baseline cognitive
      assessment, structural and functional MRI characterization, PiB-PET, and resting-state EEG
      measurement. The participants will be randomized to either a tACS group or a sham stimulation
      group. At the end of the intervention and 3-month follow-up, all subjects will repeat the
      baseline assessments.
    

Detailed description: 
      Background: Alzheimer's disease (AD) is the most prevalent cause of dementia. Given the
      limited efficacy of pharmacological treatments, non-pharmacological approaches in AD are of
      great interest. In these approaches, brain stimulation technique is an important one, because
      of its potential to modulate cognitive functions in many neuropsychiatric diseases.
      Transcranial alternating current stimulation (tACS), as a neuromodulatory technique,
      oscillates a sinusoidal current at a chosen frequency to interact with the brain's natural
      cortical oscillations. Hypothetically, tACS would reduce cortical hyperactivity and induces
      cognitive improvement or delay cognitive decline in patients with AD.

      Objectives This double-blinded, randomized controlled trial evaluates the efficacy and safety
      of tACS in patients with mild AD. The second objective is to evaluate the effect of tACS on
      neural plasticity, which is assessed by structural and functional MRI, PiB-PET, and
      resting-state EEG.

      Patients and Methods The proposed study is a double-blinded, randomized controlled trial that
      will include 40 individuals with mild AD with positive findings in amyloid PET imaging or
      amyloid protein levels in CSF. The participants will be randomized to either a tACS group or
      a sham stimulation group. Both groups will undergo 30 one-hour sessions in 3 weeks (21 days).
      All the outcomes will be assessed at baseline, end of intervention and 3 months after the
      first intervention to measure long-term resilience of the effect.
    

Intervention name(s): transcranial alternating current stimulation; sham stimulation
Intervention type(s): Device; Device
Intervention description(s): The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with gamma-frequency (40 Hz) and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).; Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment