Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment

Taipei Hospital, Ministry of Health and Welfare

Status: Completed

Conditions: Cognitive Impairment, Mild; Dementia

Treatments: Device: High-frequency repetitive transcranial magnetic stimulation (40Hz); Device: Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)

Study type: Interventional

Funder types: Other

Identifiers

NCT06192433

202314

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

High-frequency repetitive transcranial magnetic stimulation group (40Hz)

Experimental group

Description:

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.

Treatment:

Device: High-frequency repetitive transcranial magnetic stimulation (40Hz)

Moderately high-frequency repetitive transcranial magnetic stimulation group (10Hz)

Active Comparator group

Description:

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.

Treatment:

Device: Moderately high-frequency repetitive transcranial magnetic stimulation (10Hz)