Transcranial Random Noise Stimulation (tRNS)ElectroencephalographyAlzheimer DiseaseBPSD (Behavioral and Psychological Symptoms of Dementia)
Investigational drug(s) / intervention(s)
High frequency transcranial random noiseSham high frequency transcranial random noise
High frequency transcranial random noise: High frequency tRNS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
Sham high frequency transcranial random noise: In the sham condition, tRNS was delivered only during the ramp-up and ramp-down periods (30s); no current was delivered during the 30-minute intervention.
Study summary
To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.
Eligibility
Sex
ALL
Min age
45 Years
Max age
84 Years
Healthy volunteers
No
Inclusion Criteria:
* Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
* Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
* CDR score ≤ 2
* Subject under treatment by IAChE for at least 3 months.
* psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Exclusion Criteria:
* NPI ≥ 4
* CDR \> 2
* Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
* History of head injury,stroke,or other neurologic disease.
* Organic brain defects on T1 or T2 images.
* History of seizures or unexplained loss of consciousness.
* Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
* Family history of medication refractory epilepsy.
* History of substance abuse within the last 6 months.
Primary outcome measure(s)
1. Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog) — baseline, 2 weeks and 8 weeks after treatment The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to Transcranial Random Noise (tRNS). The ADAS-Cog scale is a scale used for clinical assessment of dementia patients with some memory efficiency tests, which can be used as an objective assessment of memory. The scale is considered a tool capable of providing a specific assessment of the severity of cognitive and non-cognitive behavioral impairments in people with Alzheimer's disease or dementia. The advantage of the ADAS-Cog compared to other scales used in the same clinical area is that its score quantifies clinical and impressionistic aspects of the patient assessed by the examiner, as well as objectively defined cognitive characteristics. The higher the ADAS-Cog score, the worse the cognitive function. The minimum value is 0 and the maximum is 86.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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