High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
- Conditions
- Transcranial Direct Current StimulationEarly Alzheimer's DiseaseFunctional Magnetic Resonance Imaging
- Interventions
- Other: computer-based cognitive trainingOther: HD-tDCS
- Registration Number
- NCT04599764
- Lead Sponsor
- Anhui Medical University
- Brief Summary
To investigate the clinical effect neural mechanism of high-definition transcranial direct current stimulation combined with cognitive training on early AD
- Detailed Description
Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tDCS at the hospital outpatient clinics or inpatient department. Participants were randomly allocated to anode tDCS group with cognitive training, anode tDCS group and the sham group. There are about 20 participants in each group. Participants were studied using a double-blind design. Study participants and all personnel responsible for the effects of the participants remained masked to allocated condition and allocation parameters. Only tDCS administrators had access to the randomization list; they had minimal contact with the participants, and no role in cognitive assessments. For the first 30 participants, allocation was decided by draw. For the subsequent 30 patients, allocation was according to computer generated random numbers. Each participant would be treated for 10 days in two weeks by HD-tDCS.
Before the tDCS, 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, including Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Montreal Cognitive Assessment (MoCA) and associative memory as the primary outcome measure and various other tasks and questionnaires to measure cognition(DS, Stroop test, VFT, SDMT), memory (AVLT, AMT, working memory test), emotion(HAMA-17, HAMD-14, eye-tracking technolodgy), executive function(SST, WSCT, GDT) and stimulation tolerability. All the tests are conducted in two days. The participants had receiving a magnetic resonance imaging scan in multi-modalities, and electroencephalography (EEG) record.
Evaluations were conducted one week after treatment and at the end of two weeks of treatment, as well as the Global Index of Safety to assess adverse events of the stimulation. Participants were instructed to focus their answers on the past 7/14 days. The participants had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multi-modalities, and EEG record. All tests were instructed to finished within 24 hours after the last stimulation. One month and three months after the last stimulation, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive training computer-based cognitive training Participants will receive Cognitive training daily for two weeks Anodal tDCS with Cognitive training computer-based cognitive training Participants will receive anoale tDCS daily and cognitive training for two weeks Anodal tDCS with Cognitive training HD-tDCS Participants will receive anoale tDCS daily and cognitive training for two weeks
- Primary Outcome Measures
Name Time Method Memory improved assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) changes from baseline at 7,14 days and 4,12 weeks post-treatment This is an very common clinical motor estimating scale. including orientation, language, structure, application of concepts, immediate recall of words and recognition of words, with a full score of 70. Higher scores indicate worse symptoms.
- Secondary Outcome Measures
Name Time Method LMT (Logic Memory Test) changes from baseline at 7,14 days and 4,12 weeks post-treatment The changes in LMT will constitute the secondary research outcome
MMSE(Mini Mental State Examination) changes from baseline at 7,14 days and 4,12 weeks post-treatment The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answe he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better.
special-version working memory changes from baseline at 7,14 days and 4,12 weeks post-treatment the accuracy and reaction time in working memory task
Associative Memory changes from baseline at 7,14 days and 4,12 weeks post-treatment The changes in Associative Memory will constitute the major research outcome measure used to assess response to HD-tDCS.
Trial Locations
- Locations (1)
Anhui Medical University
🇨🇳Hefei, Anhui, China