Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01369264
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2010-09-18
Brief Title:
The Effect of Repetitive Transcranial Magnetic Stimulation on Brain Activity in Healthy Human Volunteers
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation rTMS on Brain Electrical Activity in Healthy Human Volunteers
Status:
COMPLETED
Status Verified Date:
2007-07
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:
ERP
Brief Summary:
The proposed study is designed to determine whether small changes in the positioning of a transcranial magnetic stimulation coil over the frontal parts of the brain cause different patterns of brain activation measured by electroencephalography EEG and quantitative EEG QEEG
Detailed Description:
A previously recorded MRI will be loaded into Brainsight a stereotactic neuronavigation system specifically designed to be used with rTMS and the scalp surface site overlying the centre of Brodmann area 46 in the dorsolateral prefrontal cortex DLPFC of both the left and right hemisphere will be identified and marked on a spandex swim cap placed on the subjects head over 31 EEG electrodes notched to prevent eddy currents placed at international 10-20 locations Three trains of true 10 Hz 110 motor threshold MT rTMS one train each with duration24 and 8 seconds and 6 similar trains of sham rTMS 3 of active sham and 3 of inactive sham will be delivered to the left hemisphere in Brodmann area 46 in random order Eyes-closed QEEG power will be recorded across all leads over 10 second blocks for 1 minute after each 10 Hz stimulus to determine the distribution and time course of any changes in electrical potential and QEEG spectrum The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train We will also measure ERPs after 1 Hz stimulation to the right DLPFC centre of Brodmann area 46 We will administer three 60-second trains of true 1 Hz rTMS at 90 100 and 110 motor threshold and six 60-second trains of sham rTMS 3 of active sham and 3 of inactive sham with device intensity setting of 10 30 and 50 motor threshold and coil tilted at 90 degrees away form the head Part 2 location testing Twenty four to 48 hours later the swim hat will be placed on the subjects head and the neuroanatomical landmarks reconfirmed using Brainsight One true train and 1 inactive sham train of 10 Hz rTMS 10 Hz 110 MT will be delivered in random order to Brodmann area 46 and two other sites in Brodmann areas 9 and 10 The rTMS train duration will be 8 seconds The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train The same procedure will be done over the right hemisphere using 1 Hz stimulation set at 110 motor threshold True rTMS pulses at 1 Hz or inactive sham rTMS pulses will be delivered in 60 second trains to the 3 sites as described above but marked over the right DLPFC QEEG activity will be recorded for 1 minute after each stimulus train The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train Diffusion Tensor Imaging The 15 healthy subjects 18-65 years old will also undergo diffusion tensor imaging DTI along with the MRI which will add approximately 10 minutes to the MRI procedure Following a routine brain imaging protocol whole brain DTI measurements will be conducted in each subject using a single shot spin echo EPI diffusion tensor imaging sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None