Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524817
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation TBS for Early Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation TBS for Early Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Comparison of the therapeutic effects of two neuronavigated theta-pulse transcranial magnetic stimulation in patients with Alzheimers disease and their underlying neural mechanisms
Detailed Description:
All patients underwent a series of medical assessments that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation rTMS treatment Upon meeting the inclusion criteria and providing informed consent each participant will complete a series of cognitive assessments and rTMS treatments at the First Affiliated Hospital of AnHui medical university Patients were randomly allocated to rTMS group 1real 1 and rTMS group 2 real 2 In real group 1 we constructed the core damage network of mild cognitive impairment by the method of damage network mapping and targeted to modulate this network in anticipation of improving the cognitive function of the patients In real group 2 we constructed the executive control network through previous literature reports and targeted to modulate this network in anticipation of improving patients cognitive functions 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 rTMS 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 rTMS
Before the rTMS 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 ADAS-cog DS Stroop test TMT BNT-30 VFT CDT JLOT 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 patients underwent a magnetic resonance imaging MRI scan with multiple modalities
After the last treatment the MMSE MoCA and ADAS-cog 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 magnetic resonance imaging scan in multi-modalities Three 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 rTMS 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 ADAS-cog DS Stroop test TMT BNT-30 VFT CDT JLOT 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 patients underwent a magnetic resonance imaging MRI scan with multiple modalities
After the last treatment the MMSE MoCA and ADAS-cog 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 magnetic resonance imaging scan in multi-modalities Three 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