Intermittent Theta-burst Stimulation for Mild Cognitive Impairment

NCT06608316 | Recruiting

• 1 other identifier: Marco_PANG_2024_July
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives of this study are to:

1. 1.Evaluating the Impact of iTBS on Cognitive and Physical Functions: The investigators will investigate the efficacy of intermittent theta burst stimulation (iTBS) in patients with mild cognitive impairment (MCI), focusing on its effects on dual-task walking abilities, balance abilities, and cognitive function.
2. 2.Comparing Clinical Efficacy Based on Stimulation Sites: The investigators will compare the clinical efficacy of iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) versus bilateral DLPFC stimulation. This comparison aims to directly examine potential differences in therapeutic outcomes based on the site of stimulation.
3. 3.Investigating Neurophysiological Mechanisms: The investigators plan to elucidate the neurophysiological mechanisms underlying the improvements in cognitive functions and dual-task walking abilities in MCI patients facilitated by iTBS. This will be achieved using fNIRS neuroimaging of brain activity.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Intermittent Theta Burst Stimulation (iTBS); Dorsolateral Prefrontal Cortex (DLPFC); dual task walking; cognitive function

Outcome Measures

Primary Outcomes (3)

• Dual-task cost in cognition (Reaction time)

  Reaction time will be measured during dual-task conditions

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Dual-task cost in gait (gait speed)

  Gait speed under dual-task condition will be recorded

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Dual-task cost in cognition (Accuracy)

  Accuracy will be measured during dual-task conditions

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

Secondary Outcomes (6)

• Blood oxygenation level changes of the brain

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Dual-task gait performance 1 (gait variability)

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Dual-task gait performance 2 (stride length)

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Dual-task gait performance 3 (walking distance)

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Dual-task gait performance 4 (gait cadence)

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

Other Outcomes (12)

• Hong Kong Montreal Cognitive Assessment (HK-MoCA)

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• N-back test

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

• Modified-Wisconsin Card Sorting Test

  before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment

Study Arms (3)

Left DLPFC stimulation group

EXPERIMENTAL

80% resting motor threshold (RMT) iTBS stimulated the left DLPFC 4 sessions per day at 15 min intervals (3min per session), 3 days per week for 3 weeks. Sham stimulation of the right DLPFC will be performed.

Device: Intermittent Theta Burst Stimulation

Bilateral DLPFC stimulation group

EXPERIMENTAL

80% RMT iTBS stimulated the bilateral DLPFC 4 sessions per day at 15 min intervals (2 sessions on the left, 2 sessions on the right, 3 min per session), 3 days per week for 3 weeks.

Device: Intermittent Theta Burst Stimulation

Sham stimulation group

SHAM COMPARATOR

Sham coil stimulates the left and right DLPFC.

Device: Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

A novel transcranial magnetic stimulation protocol called intermittent theta pulse stimulation (iTBS) effectively mimics the brain's naturally occurring theta rhythms and promotes significant synaptic changes. Compared to traditional stimulation methods, iTBS is more effective at initiating long-term potential (LTP) and produces significant excitatory effects in a shorter period of time.

Bilateral DLPFC stimulation group; Left DLPFC stimulation group; Sham stimulation group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged≥65 years;
• Patient-reported subjective cognitive decline and the total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) was between 19 and 25;
• Intact daily functioning in ADL scales and being independent in daily living, and ability to walk at least for 1 minute independently without an assistive device;
• No serious visual or hearing impairment and can complete relevant assessment and testing;
• Signed informed consent of patients and their families for iTBS treatment.

You may not qualify if:

• Identified with contraindications in the rTMS screening questionnaire;
• Cognitive dysfunction due to craniocerebral trauma or neurological diseases;
• Presence of severe physical illnesses such as speech disorders or unstable cardiac arrhythmias;
• Currently in a critical condition such as fever, infection, or organ failure;
• Significant damage to the left frontal lobe cortex;
• Currently taking antidepressants or psychostimulants;
• Unstable vital signs or organ failure;
• Neuropsychiatric comorbidity or affective disorder that could affect the test results;
• Patients with dementia.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 000000, Hong Kong

NOT YET RECRUITING

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessors and participants were blinded to the participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment: After stratification according to gender and age, the participants will be randomly allocated to one of three groups: (1) Left DLPFC stimulation group, (2) Bilateral DLPFC stimulation group, and (3) Sham stimulation group, using a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From Dec 2027 onwards
• Access Criteria: By contacting the Principal Investigator (Prof. Marco PANG): Marco.Pang@polyu.edu.hk

Locations

HK (2)