Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565143
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Effect of Transcranial Alternating Current StimulationtACS for Early Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Transcranial Alternating Current StimulationtACS for Early Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the clinical effect neural mechanism of transcranial alternating current stimulation in early Alzheimers disease
Detailed Description:
Upon meeting the inclusion criteria and providing informed consent each participant will complete a series of cognitive assessments and tACS at the First Affiliated Hospital of Anhui medical university Patients were randomly allocated to tACS 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 and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters Only tACS administrators had access to the randomization list they had minimal contact with the patients and no role in cognitive and symptom assessments Each patient would be treated for continuous 14 days by tACS
Before the tACS 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 Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog as the primary outcome measure and various other tasks and questionnaires to measure cognition including MoCAMMSE DS Stroop test TMT BNT-30 VFT CDTJLOT Form HHVOT memory CAVLT LMT emotionHAMA-17HAMD-14GDS-30 behavioral and psychological symptomsNPI 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 months 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
Before the tACS 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 Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog as the primary outcome measure and various other tasks and questionnaires to measure cognition including MoCAMMSE DS Stroop test TMT BNT-30 VFT CDTJLOT Form HHVOT memory CAVLT LMT emotionHAMA-17HAMD-14GDS-30 behavioral and psychological symptomsNPI 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 months 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None