Trial Outcomes & Findings for Improving Rehabilitation by Magnetic Brain Stimulation (NCT NCT00636701)

Results Overview

Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

Baseline (day 0) and 2 weeks

Results posted on

2015-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Receive rTMS (Repetitive Transcranial Magnetic Stimulation) Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes	Arm 2 Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation) Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Rehabilitation by Magnetic Brain Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=2 Participants Receive rTMS (Repetitive Transcranial Magnetic Stimulation) Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes	Arm 2 n=2 Participants Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation) Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (day 0) and 2 weeks

Population: Four right-handed healthy volunteers (two men, aged 20-50 years) participated in a double-blind study of primed and unprimed rTMS.

Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .

Outcome measures

Outcome measures
Measure	Number of Participants Who Received Primed rTMS n=2 Participants Number of participants who received 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)	Number of Participants Who Received Unprimed rTMS n=2 Participants Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks	3 percentage change of BOLD Standard Deviation .5	2 percentage change of BOLD Standard Deviation .25

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Butler

Atlanta VA Medical Center

Phone: 404-413-1415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place