Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
Transcranial Random Noise (tRNS) for Behavioral and Psychological Symptoms in Alzheimer's Disease (BPSD): A Randomized, Double-blind, Sham-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kai Wang, PhD
- Phone Number: +86-0551-62922263
- Email: wangkai1964@126.com
Study Contact Backup
- Name: Xingqi Wu, PhD
- Phone Number: +8618134516380
- Email: wuxingqi09@163.com
Study Locations
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Anhui
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Hefei, Anhui, China, 230032
- Recruiting
- Anhui Medical University, Hefei, Anhui 230032
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Contact:
- Xinyu Shi
- Phone Number: 86+19105529199
- Email: 2819027557@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Transcranial random noise-Real
Participants will receive real tRNS once daily for two weeks
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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.
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Sham Comparator: Transcranial random noise-Sham
Arm Description: Participants will receive sham tRNS once daily for two weeks
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
Time Frame: baseline, 2 weeks and 8 weeks after treatment
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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.
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baseline, 2 weeks and 8 weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Associative Memory
Time Frame: baseline, 2 weeks and 8 weeks after treatment
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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.
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baseline, 2 weeks and 8 weeks after treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHMU-TRNS--BPSD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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