Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT06192433
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment
Sponsor:
Taipei Hospital, Ministry of Health and Welfare
Organization:
Study Overview
Official Title:
Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: