Effect of Transcranial Random Noise (tRNS) for Early Alzheimer's Disease
NCT ID: NCT05891444
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-06-01
2023-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Transcranial random noise-Real
Participants will receive real tRNS once daily for two weeks
High frequency transcranial random noise
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.
Transcranial random noise-Sham
Participants will receive sham tRNS once daily for two weeks
Sham high frequency transcranial random noise
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.
Interventions
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High frequency transcranial random noise
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 noise
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.
Eligibility Criteria
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Inclusion 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
* 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.
45 Years
80 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Director of medical psychological department, Anhui Medical University
Locations
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Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHMU-TRNS-AD
Identifier Type: -
Identifier Source: org_study_id
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