Study Results
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View full resultsBasic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2014-01-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Real TMS
TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease.52, 123 Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.
Real TMS
real treatment
Sham TMS
Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.
Sham TMS
placebo treatment
Interventions
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Real TMS
real treatment
Sham TMS
placebo treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of mild cognitive impairment
* No unstable medical condition
Exclusion Criteria
* Prior deep brain stimulation (DBS) or ablation surgery
* Evidence for active depression or Hospital Anxiety and Depression Scale (HADS) score greater than or equal to 11
* Motor symptoms expected to interfere with scanning (e.g. sever tremor)
* Contraindications to TMS, MEG, or MRI such as pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy, or on medications known to lower seizure threshold
* Implanted electronic devices or metal
40 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Benzi M Kluger, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Colorado School of Medicine
Locations
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University of Colorado School of Medicine
Aurora, Colorado, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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13-2724
Identifier Type: -
Identifier Source: org_study_id
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