Investigating the Effect of Transcranial Random Noise (tRNS) add-on Treatment for Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
研究概览
简要总结
To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Transcranial random noise-Real
Participants will receive real tRNS once daily for two weeks
干预措施: High frequency transcranial random noise (Device)
Transcranial random noise-Sham
Participants will receive sham tRNS once daily for two weeks
干预措施: Sham high frequency transcranial random noise (Device)
结局指标
主要结局
Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
时间窗: 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.
Associative Memory
时间窗: baseline, 2 weeks and 8 weeks after treatment
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.
次要结局
- DST (Digital Span Test; Forward and Backward)(baseline, 2 weeks and 8 weeks after treatment)
- TMT (Trail Making Test)(baseline, 2 weeks and 8 weeks after treatment)
- HAMA (Hamilton Anxiety Scale)(baseline, 2 weeks and 8 weeks after treatment)
- The changes in MMSE(Mini Mental State Examination)(baseline, 2 weeks and 8 weeks after treatment)
- HVOT(Hooper visual organization test Hooper visual organization test)(baseline, 2 weeks and 8 weeks after treatment)
- HAMD (Hamilton Depression Scale)(baseline, 2 weeks and 8 weeks after treatment)
- NPI (Neuropsychiatric Inventory)(baseline, 2 weeks and 8 weeks after treatment)
- changes in Montreal Cognitive Assessment (MoCA)(baseline, 2 weeks and 8 weeks after treatment)
- GDS(Geriatric depression scale)(baseline, 2 weeks and 8 weeks after treatment)
- JLOT(Judgment of line Judgment of line orientation test orientation test)(baseline, 2 weeks and 8 weeks after treatment)
- EEG power in the typical spectral bands(baseline, 2 weeks and 8 weeks after treatment)
- The Stroop color test(baseline, 2 weeks and 8 weeks after treatment)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University