Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04555941
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2020-08-25
Brief Title:
The Effects of Intermittent Theta Burst Stimulation in MCI and Early AD
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Taipei Medical University Shuang Ho Hospital
Study Overview
Official Title:
Cognitive Effects of Theta Burst Stimulation in Mild Cognitive Impairment and Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Transcranial magnetic stimulation TMS is a noninvasive brain stimulation technique that is increasingly used for a growing number of research and clinical applicationsTypically this transient magnetic field is focally applied with a figure-of-eight coil that is carefully placed on the surface of the scalp over a targeted stimulation site Patterned repetitive TMS rTMS such as theta burst stimulation TBS can produce long-lasting effects on neural activity and behavior beyond the stimulation period Chou et al 2015a Fitzgerald et al 2006 In general high frequency 5 Hz rTMS and its newer version intermittent theta burst stimulation iTBS facilitate cortical excitability whereas low frequency about 1 Hz rTMS and continuous theta burst stimulation contribute to opposite effects Pascual-Leone et al 2000 Huang et al 2005 Wassermann and Zimmermann 2012Careful manipulation of the parameters comprising these patterned rTMS pulse trains can induce neuroplastic changes that resemble either long-term potentiation LTP or depression Chen et al 1997 Pascual-Leone et al 1994 Early studies targeting the motor cortex helped elucidate which rTMS parameters promote particular responses and their neurophysiological underpinnings Klomjai et al 2015
In recent years rTMS has been closely investigated to evaluate its potential to modulate cognitive functions in Alzheimersdisease AD and mild cognitive impairment MCI As compared to conventional excitatory rTMS protocols iTBS leads to comparable effects with similar number of pulses but considerable shorter duration and lower intensity of stimulation Bakker et al 2015 Rossi Hallett Rossini Pascual-Leone Safety 2009 Recent literature also suggest that TBS has lower rates of reported adverse event AE compared to rTMS Najib Horvath 2014 Therefore iTBS is assumed to modulate cognitive function in people with cognitive impairments
In recent years rTMS has been closely investigated to evaluate its potential to modulate cognitive functions in Alzheimersdisease AD and mild cognitive impairment MCI As compared to conventional excitatory rTMS protocols iTBS leads to comparable effects with similar number of pulses but considerable shorter duration and lower intensity of stimulation Bakker et al 2015 Rossi Hallett Rossini Pascual-Leone Safety 2009 Recent literature also suggest that TBS has lower rates of reported adverse event AE compared to rTMS Najib Horvath 2014 Therefore iTBS is assumed to modulate cognitive function in people with cognitive impairments
Detailed Description:
Visit 1 Informed Consent Brain MRINeuropsychological Battery
Visit 2-11 up to a week after visit 1 iTBS - or Sham-Treatment 10 sessions 80 Resting Motor Threshold 2s stimulation 8s inter-stimulus interval per train 20 trains per block 3 blocks per session with a 5-min break 1 session per day
Visit 12 1 day or same day after visit 11 Functional Brain MRINeuropsychological Battery
Visit 13 4 weeks after visit 11 Functional Brain MRINeuropsychological Battery
Visit 2-11 up to a week after visit 1 iTBS - or Sham-Treatment 10 sessions 80 Resting Motor Threshold 2s stimulation 8s inter-stimulus interval per train 20 trains per block 3 blocks per session with a 5-min break 1 session per day
Visit 12 1 day or same day after visit 11 Functional Brain MRINeuropsychological Battery
Visit 13 4 weeks after visit 11 Functional Brain MRINeuropsychological Battery
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?:
None
Is an FDA AA801 Violation?:
None