Transcranial Random Noise Stimulation (tRNS)NCT07827196
Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
A study testing High frequency transcranial random noise in people with Transcranial Random Noise Stimulation (tRNS) and Electroencephalography, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG. Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- Transcranial Random Noise Stimulation (tRNS), Electroencephalography, Alzheimer Disease
- What is being tested?
- High frequency transcranial random noise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University, Hefei, Anhui 230032
Hefei, Anhui, 230032
Xinyu Shi, 86+19105529199, 2819027557@qq.com
About this study
Official title: Transcranial Random Noise (tRNS) for Behavioral and Psychological Symptoms in Alzheimer's Disease (BPSD): A Randomized, Double-blind, Sham-Controlled Trial
To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.
Read the detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after Transcranial random noise (tRNS) treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tRNS treatments at the First Affiliated Hospital of AnHui medical university. Patients were randomly allocated to tRNS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tRNS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and synptom assessments. Each patient would be treated for continuous 14 days by tRNS. The stimulation electrodes were arranged in a 4 × 1 ring at AFz, FCz, F7, C5 and F3, with the central electrode producing a random alternating current of 1.5ma and the surrounding 4 electrodes producing 1/4 of the current of the central electrode. At 100-640 Hz tRNS, participants had a mean interpeak-to-peak stimulation intensity of 1.5mA. Under the sham conditions, 100-640 Hz tRNS were delivered only during the ascent and descent phases (30 seconds); No current was transmitted during the 30-minute intervention. The tRNS stimulation lasted for 30 minutes, which is common in cognitive neuroscience research.
Before the tRNS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the associative memory as the primary outcome measure and various other tasks and questionnaires to measure cognition(including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two month after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
- Conditions
- Transcranial Random Noise Stimulation (tRNS), Electroencephalography, Alzheimer Disease, BPSD (Behavioral and Psychological Symptoms of Dementia)
- Being tested
- High frequency transcranial random noise, Sham high frequency transcranial random noise
- Keywords
- Transcranial random noise, electroencephalography, Alzheimer Disease, BPSD (behavioral and psychological symptoms of dementia)
- Medical subject headings
- Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency transcranial random noiseDevice
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 noiseDevice
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 group | Role | What they receive |
|---|---|---|
| Transcranial random noise-Real | Active comparator | Participants will receive real tRNS once daily for two weeks Receives: Device: High frequency transcranial random noise |
| Transcranial random noise-Sham | Sham comparator | Arm Description: Participants will receive sham tRNS once daily for two weeks Receives: Device: Sham high frequency transcranial random noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
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.
Measured: baseline, 2 weeks and 8 weeks after treatment
Secondary outcomes (1)
Associative Memory
The changes in Associative Memory will constitute the major research outcome measure used to assess response to tRNS. The associative memory test uses facial cue word recall. The subjects memorized 20 photos of faces displayed on a screen in gray scale for 4 seconds each. When each card was presented, a common word appeared alongside the face. The subjects had to remember associations between faces and words by association. After a delay of about a minute after the study ended, the subjects were shown 12 of the same faces in different random orders, instructing them to recall the words that appeared with each face during the study. Recorded the correct number of words each face recalled. The faces were taken from a database of 24 amateur models. Each test format included only male or female faces.
Measured: baseline, 2 weeks and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Random Noise Stimulation (tRNS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827196
- Sponsor's protocol ID
- AHMU-TRNS--BPSD
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Random Noise (tRNS) for Behavioral and Psychological Symptoms in Alzheimer's Disease (BPSD): A Randomized, Double-blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07827196
- Acronym / sponsor ID
- AHMU-TRNS--BPSD
- Conditions
- Transcranial Random Noise Stimulation (tRNS), Electroencephalography, Alzheimer Disease, BPSD (Behavioral and Psychological Symptoms of Dementia)
- Keywords
- Transcranial random noise, electroencephalography, Alzheimer Disease, BPSD (behavioral and psychological symptoms of dementia)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.
Detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after Transcranial random noise (tRNS) treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tRNS treatments at the First Affiliated Hospital of AnHui medical university. Patients were randomly allocated to tRNS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tRNS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and synptom assessments. Each patient would be treated for continuous 14 days by tRNS. The stimulation electrodes were arranged in a 4 × 1 ring at AFz, FCz, F7, C5 and F3, with the central electrode producing a random alternating current of 1.5ma and the surrounding 4 electrodes producing 1/4 of the current of the central electrode. At 100-640 Hz tRNS, participants had a mean interpeak-to-peak stimulation intensity of 1.5mA. Under the sham conditions, 100-640 Hz tRNS were delivered only during the ascent and descent phases (30 seconds); No current was transmitted during the 30-minute intervention. The tRNS stimulation lasted for 30 minutes, which is common in cognitive neuroscience research.
Before the tRNS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the associative memory as the primary outcome measure and various other tasks and questionnaires to measure cognition(including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two month after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial random noise-Real | Active comparator | Device: High frequency transcranial random noiseParticipants will receive real tRNS once daily for two weeks |
| Transcranial random noise-Sham | Sham comparator | Device: Sham high frequency transcranial random noiseArm Description: Participants will receive sham tRNS once daily for two weeks |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency transcranial random noiseHigh 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. | Device | Transcranial random noise-Real |
| Sham high frequency transcranial random noiseIn 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. | Device | Transcranial random noise-Sham |
Primary outcome
1. Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
Time frame: 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.
1 secondary outcome
Associative Memory
Time frame: baseline, 2 weeks and 8 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency transcranial random noise in people with Transcranial Random Noise Stimulation (tRNS) and Electroencephalography, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62922263, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog) (time frame: baseline, 2 weeks and 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.