NCT03612622

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

Investigating the Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) add-on Treatment for Early Alzheimer's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To investigate the treatment effect of theta-burst transcranial magnetic stimulation on Alzheimer patients, and the underlying neural mechanism by MRI.

Detailed description

All patients underwent a medical evaluation 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 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, 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 synptom assessments. Each patient would be treated for continuous 15 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, 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 had receiving a magnetic resonance imaging scan in multi-modalities. 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 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multi-modalities. 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

• Transcranial Magnetic Stimulation
• Magnetic Resonance Imaging
• Alzheimer Disease

Interventions

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

Timeline

• Start date: 2018-08-14
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2018-08-02
• Last updated: 2021-02-02

Locations

1 site across 1 country: China