NCT06192433

Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment

Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Taipei Hospital, Ministry of Health and Welfare · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Cognitive Impairment, Mild

Interventions

Type	Name	Description
DEVICE	High-frequency repetitive transcranial magnetic stimulation (40Hz)	Participants in this group receive high-frequency TMS at 40 Hz. The TMS intervention is applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient undergoes this TMS treatment for a course of 10 consecutive working days. The specific parameters for TMS include pulses at 40 Hz with an intensity set at 40% of the maximum intensity. Each pulse lasts for 2 seconds, followed by a 58-second rest period. On each treatment day, patients receive 30 sets of stimulation, with 15 stimulations applied to the left side and 15 to the right side, totaling 2400 pulses.
DEVICE	Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)	Participants in this group receive moderately high-frequency TMS at 10 Hz. Similar to the high-frequency group, the TMS intervention targets the bilateral dorsolateral prefrontal cortex (DLPFC) and is administered for a course of 10 consecutive working days. The TMS parameters for this group involve pulses at 10 Hz with an intensity set at 90% of the maximum intensity. Each pulse lasts for 4 seconds, followed by a 56-second rest period. As in the high-frequency group, patients in this group also receive 30 sets of stimulation per treatment day, with 15 stimulations applied to the left side and 15 to the right side, totaling 2400 pulses.

Timeline

• Start date: 2023-07-26
• Primary completion: 2024-04-19
• Completion: 2024-06-19
• First posted: 2024-01-05
• Last updated: 2024-11-21

Locations

1 site across 1 country: Taiwan