NCT06524817

Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation (TBS) for Early Alzheimer's Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the therapeutic effects of two neuronavigated theta-pulse transcranial magnetic stimulation in patients with Alzheimer's 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 1(real 1) and rTMS group 2 (real 2). In real group 1, the investigators 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, the investigators 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 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 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.

Conditions

• Alzheimer Disease
• Transcranial Magnetic Stimulation
• Neuronavigation

Interventions

Type	Name	Description
OTHER	transcranial magnetic stimulation	Neuronavigated Theta-Burst Transcranial Magnetic Stimulation

Timeline

• Start date: 2023-09-10
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2024-07-29
• Last updated: 2025-04-01

Locations

1 site across 1 country: China