Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease (TRANSFORM-AD)
- Conditions
- Alzheimer Disease
- Interventions
- Device: transcranial alternating current stimulationDevice: sham stimulation
- Registration Number
- NCT03920826
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tACS stimulation group transcranial alternating current stimulation NEXALIN ADI transcranial alternating current stimulator sham stimulation group sham stimulation Sham stimulator provided by NEXALIN company
- Primary Outcome Measures
Name Time Method Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version). up to 21 days (end of intervention) ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
- Secondary Outcome Measures
Name Time Method Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version). 3 months ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
Change in brain connectivity up to 21 days (end of intervention), 3 months Functional MRI and resting-state EEG will be used to measure brain connectivity.
Change in Digit span forward up to 21 days (end of intervention), 3 months Digit span will be used to assess attention. It ranges from 3 to 10, and higher value represents a better outcome.
Side-effects of tACS up to 21 days (end of intervention), 3 months Adverse Events as a result of tACS stimulation will be reported.
Change in brain volume and white matter integrity up to 21 days (end of intervention), 3 months Structural MRI will be used to measure brain volume and white matter integrity.
Change in memory function up to 21 days (end of intervention), 3 months WHO-UCLA Auditory Verbal Learning Test will be used to assess memory function. It ranges from 0 to 45, and higher value represents a better outcome.
Change in Trail Making Test up to 21 days (end of intervention), 3 months Trail-Making Test B minus A score will be used to assess executive function. Trail-Making Test B minus A ranges from -150 to 300, higher value represents a worse outcome.
Change in Neuropsychiatric Inventory (NPI) up to 21 days (end of intervention), 3 months The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome.
Change in Geriatric Depression Scale (GDS) up to 21 days (end of intervention), 3 months The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.
Change in amyloid deposit in brain up to 21 days (end of intervention) PiB-PET will be used to analyze the amyloid deposit in brain.
Change in Clinical Dementia Rating Scale sum of the boxes up to 21 days (end of intervention), 3 months Clinical Dementia Rating Scale sum of the boxes (CDR-SB) will be used to evaluate the general cognitive function. CDR-SB ranges from 0 to 18, and higher value represents a worse outcome.
Change in Boston Naming Test up to 21 days (end of intervention), 3 months Boston Naming Test will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.
Change in Activities of Daily Living up to 21 days (end of intervention), 3 months Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.
Change in Mini-mental State Examination up to 21 days (end of intervention), 3 months Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Change in Montreal Cognitive Assessment up to 21 days (end of intervention), 3 months Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Change in Digit span backward up to 21 days (end of intervention), 3 months Digit span backward will be used to assess executive function. It ranges from 2 to 8, and higher value represents a better outcome.
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, China