Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment

Dementia Clinical Trial

Official title:

Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192433
• Other study ID #: 202314
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: June 19, 2024

Study information

• Verified date: October 2023
• Source: Taipei Hospital, Ministry of Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Ministry of Health and Welfare	New Taipei City	ROC

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Dementia Rating (CDR)	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.	pre treatment / ten days later (post treatment)
Primary	Mini-Mental State Examination (MMSE)	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.	pre treatment / ten days later (post treatment)
Primary	Montreal Cognitive Assessment (MoCA):	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.	pre treatment / ten days later (post treatment)
Primary	N-Back Test	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.	pre treatment / ten days later (post treatment)
Primary	Stroop Color Word Test (SWCT)	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.	pre treatment / ten days later (post treatment)
Primary	Wisconsin Card Sorting Test (WCST)	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.	pre treatment / ten days later (post treatment)