Clinical trial NCT06192433: Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment
Official title: Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Cognitive Impairment, Mild
Keywords: high-frequency transcranial magnetic stimulation
cognitive impairment
Dementia
Lead sponsor: Taipei Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a Randomized Controlled Trial designed to investigate the effects of different frequencies of transcranial magnetic stimulation (TMS) as non-pharmacological treatment for patients with mild cognitive impairment or dementia. The trial employs a Parallel Study Design, where two groups of participants are treated concurrently with either high-frequency transcranial magnetic stimulation (40 Hz rTMS) or moderately high-frequency transcranial magnetic stimulation (10 Hz rTMS).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Dementia Rating (CDR)
timeFrame: pre treatment / ten days later (post treatment)
measure: Mini-Mental State Examination (MMSE)
timeFrame: pre treatment / ten days later (post treatment)
measure: Montreal Cognitive Assessment (MoCA):
timeFrame: pre treatment / ten days later (post treatment)
measure: N-Back Test
timeFrame: pre treatment / ten days later (post treatment)
measure: Stroop Color Word Test (SWCT)
timeFrame: pre treatment / ten days later (post treatment)
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: pre treatment / ten days later (post treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
state: ROC
Study officials:
References: