Clinical trial NCT06524817: Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation (TBS) for Early Alzheimer's Disease
Official title: Effect of Neuronavigated Theta-Burst Transcranial Magnetic Stimulation (TBS) for Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Transcranial Magnetic Stimulation
Neuronavigation
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
2. Subjects must have a MMSE score between 15 and 27,indicating mild cognitive impairment or dementia.
3. CDR score ≤ 1.
4. Subject under treatment by IAChE for at least 3 months.
5. psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months.

Exclusion Criteria:

1. CDR \> 1.
2. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
3. History of head injury,stroke,or other neurologic disease.
4. Organic brain defects on T1 or T2 images.
5. History of seizures or unexplained loss of consciousness.
6. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
7. Family history of medication refractory epilepsy.
8. History of substance abuse within the last 6 months.

Primary outcomes:
measure: Mini Mental State Examination(MMSE)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Digital Span Test; Forward and Backward(DST)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Trail Making Test(TMT )
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Hamilton Depression Scale(HAMD )
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Hamilton Anxiety Scale(HAMA)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Neuropsychiatric Inventory(NPI)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Geriatric depression scale(GDS)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Judgment of line Judgment of line orientation test orientation test(JLOT)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Hooper visual organization test Hooper visual organization test(HVOT)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: The Stroop color test
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: EEG power in the typical spectral bands
timeFrame: baseline, 2 weeks and 12 weeks after treatment
measure: Logic Memory Test(LMT)
timeFrame: baseline, 2 weeks and 12 weeks after treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: