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

NCT06524817 | Withdrawn

• 1 other identifier: Anhui-NTBS-AD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer Disease; Transcranial Magnetic Stimulation; Neuronavigation

Outcome Measures

Primary Outcomes (2)

• Mini Mental State Examination(MMSE)

  The changes in MMSE will constitute the primary research outcome.The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answer he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better. In this study, changes in MMSE scores before and after treatment were used as primary observations,the investigators hoped that scores would increase after treatment.

  baseline, 2 weeks and 12 weeks after treatment

• Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)

  The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to transcranial magnetic stimulation (TMS).The ADAS-COG scale tests orientation, language, structure, use of ideas, immediate recall of words and word re-recognition, and consists of 11 questions out of a possible 70 points, with the higher the score the more cognitively impaired.

  baseline, 2 weeks and 12 weeks after treatment

Secondary Outcomes (12)

• Montreal Cognitive Assessment (MoCA)

  baseline, 2 weeks and 12 weeks after treatment

• Digital Span Test; Forward and Backward(DST)

  baseline, 2 weeks and 12 weeks after treatment

• Trail Making Test(TMT )

  baseline, 2 weeks and 12 weeks after treatment

• Hamilton Depression Scale(HAMD )

  baseline, 2 weeks and 12 weeks after treatment

• Hamilton Anxiety Scale(HAMA)

  baseline, 2 weeks and 12 weeks after treatment

Study Arms (2)

Transcranial Magnetic Stimulation-Real 1

ACTIVE COMPARATOR

Participants will receive active real 1 TMS once daily for two weeks

Other: transcranial magnetic stimulation

Transcranial Magnetic Stimulation-Real 2

ACTIVE COMPARATOR

Participants will receive active real 2 TMS once daily for two weeks

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation OTHER

Neuronavigated Theta-Burst Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation-Real 1; Transcranial Magnetic Stimulation-Real 2

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
• Subjects must have a MMSE score between 15 and 27,indicating mild cognitive impairment or dementia.
• CDR score ≤ 1.
• 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.

You may not qualify if:

• CDR \> 1.
• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department, Anhui Medical University

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: September 10, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CN (1)