Clinical trial NCT04599764: High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
Official title: High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Functional Magnetic Resonance Imaging
Early Alzheimer's Disease
Keywords: High Definition Transcranial Direct Current Stimulation
Functional Magnetic Resonance Imaging
Neuropsychology
Early Alzheimer's Disease
Working Memory
Alzheimer's Disease Assessment Scale-Cognitive Subscale
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Memory improved assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
timeFrame: changes from baseline at 7,14 days and 4,12 weeks post-treatment
Secondary outcomes:
measure: special-version working memory
timeFrame: changes from baseline at 7,14 days and 4,12 weeks post-treatment
measure: Associative Memory
timeFrame: changes from baseline at 7,14 days and 4,12 weeks post-treatment
measure: MMSE(Mini Mental State Examination)
timeFrame: changes from baseline at 7,14 days and 4,12 weeks post-treatment
measure: LMT (Logic Memory Test)
timeFrame: changes from baseline at 7,14 days and 4,12 weeks post-treatment
Other outcomes:
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: TMT (Trail Making Test)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: HAMD (Hamilton Depression Scale)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: NPI (Neuropsychiatric Inventory)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: MRI measures
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: changes in Montreal Cognitive Assessment (MoCA)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: GDS(Geriatric depression scale)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: JLOT(Judgment of line Judgment of line orientation test orientation test)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: HVOT(Hooper visual organization test Hooper visual organization test)
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
measure: The Stroop color test
timeFrame: changes from baseline at 14 days and 4,12 weeks post-treatment
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: