Gentle Brain Stimulation for Behavioral Symptoms in Alzheimer's Disease
Tests gentle brain stimulation against a sham in people with Alzheimer's disease.
Key facts
- Who runs it
- Anhui Medical University
- Where
- Hefei, ChinaSee the site
- Trial code
- Registry title
- Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 1 Sept 2026
- Expected to end
- 1 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- High frequency transcranial random noise
- Sham high frequency transcranial random noise
- Record updated
- 18 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 45 to 84 with early Alzheimer's disease who already take an acetylcholinesterase-inhibitor drug (IAChE). It tests a brain stimulation device against a sham (fake) version.
- Age
- 45 to 84 years
- Sex
- Women and men can join.
- Disease stage
- Early Alzheimer's disease or related diseases (NINCDS-ACDRADA criteria). MMSE score between 10 and 27. CDR score of 2 or less.
- Earlier treatment
- Must have been treated with an IAChE drug for at least 3 months. Psychotropic drugs are accepted if given and unchanged for at least 3 months.
Main reasons for not taking part
- NPI of 4 or more, or CDR above 2
- Other severe psychiatric illness, such as major depression, psychosis or obsessive compulsive disorder
- History of head injury, stroke or other neurologic disease
- History of seizures or unexplained loss of consciousness
- Implanted pacemaker, medication pump, vagal stimulator or deep brain stimulator
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator
- 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
- History of seizures or unexplained loss of consciousness
- Family history of medication refractory epilepsy
- History of substance abuse within the last 6 months
- NPI ≥ 4
- CDR > 2
- Organic brain defects on T1 or T2 images
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 84 years old?
Where in China
- Anhui Medical University, Hefei, Anhui 230032Hefei, ChinaContact: Xinyu ShiTaking people
About the trial
What the trial wants to find out
To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.
The 2 groups in the trial
- Transcranial random noise-RealExisting treatment, for comparison
Participants will receive real tRNS once daily for two weeks
Treatment: High frequency transcranial random noise
- Transcranial random noise-ShamSham treatment, for comparison
Arm Description: Participants will receive sham tRNS once daily for two weeks
Treatment: Sham high frequency transcranial random noise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Transcranial Random Noise (tRNS) for Behavioral and Psychological Symptoms in Alzheimer's Disease (BPSD): A Randomized, Double-blind, Sham-Controlled Trial
- Plain-language title
- Gentle Brain Stimulation for Behavioral Symptoms in Alzheimer's DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07827196, who can take part
- Record updated
- 18 September 2026