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

NCT ID: NCT03612622

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2020-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Transcranial Magnetic Stimulation-Real

Participants will receive active TMS once daily for two weeks

Group Type: ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type: OTHER

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation-Sham

Participants will receive sham TMS once daily for two weeks

Group Type: PLACEBO_COMPARATOR

transcranial magnetic stimulation

Intervention Type: OTHER

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Interventions

transcranial magnetic stimulation

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA 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

• CDR > 2
• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Director of medical psychological department, Anhui Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

Anhui medical university

Identifier Type: -

Identifier Source: org_study_id