Clinical trial NCT03612622: Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Early Alzheimer's Disease
Official title: Investigating the Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) add-on Treatment for Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Alzheimer Disease
Keywords: Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Alzheimer Disease
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Associative Memory
timeFrame: baseline, 2 weeks and 8 weeks after treatment
Secondary outcomes:
measure: The changes in MMSE(Mini Mental State Examination)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: LMT (Logic Memory Test)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: TMT (Trail Making Test)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: HAMD (Hamilton Depression Scale)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: NPI (Neuropsychiatric Inventory)
timeFrame: baseline, 4 weeks after treatment
measure: MRI measures
timeFrame: baseline, 2 weeks after treatment
measure: 2-BACK(special-version)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: changes in Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: GDS(Geriatric depression scale)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: JLOT(Judgment of line Judgment of line orientation test orientation test)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: HVOT(Hooper visual organization test Hooper visual organization test)
timeFrame: baseline, 2 weeks and 8 weeks after treatment
measure: The Stroop color test
timeFrame: baseline, 2 weeks and 8 weeks after treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: