Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment

Not Applicable

Completed

• Conditions: Dementia; Cognitive Impairment, Mild
• Interventions: Device: High-frequency repetitive transcranial magnetic stimulation (40Hz); Device: Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)

• Registration Number: NCT06192433
• Lead Sponsor: Taipei Hospital, Ministry of Health and Welfare

Brief Summary

Introduction and Purpose:

In recent years, non-pharmacological treatment methods for dementia patients have been gradually explored. Among these, Transcranial Magnetic Stimulation (TMS) has been proposed as a non-invasive treatment option. However, the optimal frequency and stimulation site for repetitive transcranial magnetic stimulation have not been definitively determined.

Methods:

This study is a randomized controlled trial. We randomly assigned 30 patients with mild cognitive impairment or dementia to the high-frequency transcranial magnetic stimulation group (40 Hz rTMS) or the moderately high-frequency transcranial magnetic stimulation group (10 Hz rTMS). Stimulation was applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient received a course of treatment for 10 consecutive working days. The high-frequency group received pulses at 40 Hz with an intensity of 40% of the maximum intensity for 2 seconds followed by a 58-second rest period, per set. The moderately high-frequency group received pulses at 10 Hz with an intensity of 90% of the maximum intensity for 4 seconds followed by a 56-second rest period, per set. Each day, patients received 30 sets of stimulation (15 times on the left side and 15 times on the right side), totaling 2400 pulses. Cognitive assessments were conducted on patients before and after the treatment course. Quantitative analysis will be performed using the Statistical Package for the Social Sciences statistical software. The Kolmogorov-Smirnov test will be used to check if the data follows a normal distribution. The chi-squared test will compare differences in baseline categorical variables between the groups, while independent t-tests or the Mann-Whitney U Test will compare baseline differences in continuous variables to assess the effectiveness of random assignment. Analysis of variance (ANOVA) and post-hoc comparisons will be used to compare intergroup and intragroup differences. The significance level is set at α = 0.05.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-26
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-05
• Primary Completion: 2024-04-19
• Study Completion: 2024-06-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Age 60 and above.
2. Have received at least 2 years of education.
3. Diagnosed with dementia or Mild Cognitive Impairment (MCI).
4. Clinical Dementia Rating (CDR) score of ≥0.5.

Exclusion Criteria

1. Mental illness.
2. Alcohol or substance addiction.
3. History of heart rhythm disorders.
4. History of epilepsy.
5. History of brain injury.
6. Underwent neurosurgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-frequency repetitive transcranial magnetic stimulation group (40Hz)	High-frequency repetitive transcranial magnetic stimulation (40Hz)	High-Frequency Group (40Hz): Participants in this arm receive high-frequency transcranial magnetic stimulation (rTMS) at 40Hz for a specified duration and intensity on the bilateral dorsolateral prefrontal cortex (DLPFC). The stimulation parameters and rest periods are outlined in the study description.
Moderately high-frequency repetitive transcranial magnetic stimulation group (10Hz)	Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)	Moderately High-Frequency Group (10Hz): Participants in this arm receive moderately high-frequency transcranial magnetic stimulation (TMS) at 10Hz for a specified duration and intensity on the bilateral dorsolateral prefrontal cortex (DLPFC). The stimulation parameters and rest periods are outlined in the study description.

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Examination (MMSE)	pre treatment / ten days later (post treatment)	The MMSE consists of seven major domains: orientation, attention, memory, language, verbal comprehension, ability to perform tasks, and constructional ability. The total score is 30 points, with a cutoff typically set at 24 points; a score of 23 or lower indicates cognitive impairment.
Stroop Color Word Test (SWCT)	pre treatment / ten days later (post treatment)	Also known as the Color-Word Conflict Test, it requires the individual to quickly read the color of the text (e.g., red, blue, green) rather than its meaning.
N-Back Test	pre treatment / ten days later (post treatment)	The N-Back task is a series of stimuli that requires participants to respond when the current stimulus matches one presented n times before. In this study, a 2-Back test is used, meaning participants are asked to respond when they detect a stimulus that matches the one presented 2 stimuli ago.
Clinical Dementia Rating (CDR)	pre treatment / ten days later (post treatment)	The Clinical Dementia Rating is an assessment tool that primarily focuses on six domains: memory, orientation, judgment and problem-solving ability, community affairs, home and hobbies, and personal care. The questionnaire consists of two parts: the first part is answered by a caregiver and provides basic information about the individual (standard answers), while the second part is answered by the individual to compare against the answers from the first part. Each domain is scored from 0 to 3, with higher scores indicating more severe symptoms.
Montreal Cognitive Assessment (MoCA):	pre treatment / ten days later (post treatment)	The test consists of 30 points and takes 10 minutes for the individual to complete. The basics of this test include short-term memory, executive function, attention, focus, and more.
Wisconsin Card Sorting Test (WCST)	pre treatment / ten days later (post treatment)	The WCST involves using four stimulus cards and a reference card. Participants are not informed of the pairing rules (color, shape, number form) and must choose a stimulus card to match with a response card. The tester provides feedback as "correct" or "incorrect." When the participant correctly pairs 10 cards in a row using the same rule, the tester changes the pairing rule. This test assesses the individual's executive function.

Trial Locations

Locations (1)

Taipei Hospital, Ministry of Health and Welfare; 🇨🇳 New Taipei City, ROC, Taiwan