Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396552
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2006-11-06
Brief Title:
Treating Refractory Obsessive Compulsive Disorder With rTMS
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Treating Refractory Obsessive Compulsive Disorder With Repetitive Transcranial Magnetic Stimulation A Double-blind Sham Controlled Longitudinal Study
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Obsessive-compulsive disorder OCD is a severe psychiatric condition with only limited response to current first-line treatments comprising pharmacotherapy and cognitive-behavioural therapy Repetitive transcranial magnetic stimulation rTMS is a relatively new technique which has shown great promise in the treatment of refractory mood disorders and schizophrenia by alteration of brain activity Previous work has demonstrated altered cortical excitability in OCD and preliminary studies have suggested that rTMS may have therapeutic potential in OCD This pilot study will investigate the effectiveness of rTMS for treatment-refractory OCD and establish appropriate treatment parameters In addition mechanisms whereby rTMS exerts its therapeutic effect will be explored using TMS to evaluate cortical inhibition and measures of cognitive biases and processing
Detailed Description:
Obsessive-compulsive disorder OCD is a severe and debilitating psychiatric illness characterized by intrusive unwanted thoughts obsessions and repetitive or ritualistic actions intended to reduce anxiety compulsions OCD is common with lifetime prevalence estimated at 25 equally affecting both genders and all ethnic groups It is also typically chronic in nature resulting in substantial impact on quality of life Functioning can be markedly impaired it has been estimated that 20 of individuals with OCD should be considered severely affected Although the pathophysiology is unclear hyperactivity in the prefrontal orbital cortex has been consistently demonstrated and normalizes with treatment A decrease in cortical inhibition has been implicated in OCD utilizing a variety of methods including paired-pulse TMS
First-line treatment typically consists of either cognitive-behavioural therapy andor pharmacotherapy with serotonin reuptake inhibitors SSRIs or clomipramine Ordinarily only modest benefits are obtained with conventional pharmacotherapy with the majority of patients considered nonresponsive or only partially responsive The limited success of conventional treatment makes identifying alternative treatments a priority Although psychosurgery is regarded as a valid alternative for severe and refractory individuals the potential for serious and irreversible adverse consequences is significant rendering this a treatment of last resort only Repetitive TMS appears to represent a safe and effective alternative for severe sufferers
Repetitive TMS has been shown to be an effective therapeutic tool for the treatment of several neuropsychiatric disorders including MDD and schizophrenia but investigations into its utility in OCD are very preliminary In a study of 12 OCD patients single session stimulation of the right lateral prefrontal cortex 20 Hz 80 motor threshold for 20 minutes resulted in a decrease in compulsive urges for eight hours in contrast to the left prefrontal cortex which was associated with more modest response Sachdev et al randomly assigned 12 individuals to receive right or left dorsolateral prefrontal stimulation 10 Hz110 resting motor threshold 15 minutes 5 sessionsweek for 2 weeks Subjects showed significant improvement at two weeks and 1-month follow-up regardless of lateralit A randomized controlled trial comparing right prefrontal stimulation to sham treatment in 18 OCD subjects was negative however low frequency 1 Hz stimulation was used in contrast to previous reports 110 motor threshold 20 minutes 3 timesweek for 6 weeks Most recently a small study of 10 individuals with OCD andor Tourettes syndrome found benefit with low-frequency stimulation of the supplementary motor area 1 Hz 100 motor threshold 20 minutes 5 sessionsweek for 2 weeks Notably subjects were treatment-resistant in both this and the Sachdev study Thus although this limited literature precludes any definitive conclusions it suggests that rTMS may be of benefit in refractory OCD
In this study we propose to investigate the effectiveness of rTMS treatment in refractory OCD Although ideal treatment parameters need to be established the above literature suggests that high frequency stimulation of the dorsolateral prefrontal cortex is likely to be beneficial Bilateral stimulation will be used our previous work has demonstrated this method to be safe and well tolerated Moreover patients will be assigned in randomized double-blind fashion to receive either active or sham TMS allowing for more definitive conclusions to be drawn We also propose to explore whether the induction of CI mediates the therapeutic effects of rTMS on OCD symptoms
First-line treatment typically consists of either cognitive-behavioural therapy andor pharmacotherapy with serotonin reuptake inhibitors SSRIs or clomipramine Ordinarily only modest benefits are obtained with conventional pharmacotherapy with the majority of patients considered nonresponsive or only partially responsive The limited success of conventional treatment makes identifying alternative treatments a priority Although psychosurgery is regarded as a valid alternative for severe and refractory individuals the potential for serious and irreversible adverse consequences is significant rendering this a treatment of last resort only Repetitive TMS appears to represent a safe and effective alternative for severe sufferers
Repetitive TMS has been shown to be an effective therapeutic tool for the treatment of several neuropsychiatric disorders including MDD and schizophrenia but investigations into its utility in OCD are very preliminary In a study of 12 OCD patients single session stimulation of the right lateral prefrontal cortex 20 Hz 80 motor threshold for 20 minutes resulted in a decrease in compulsive urges for eight hours in contrast to the left prefrontal cortex which was associated with more modest response Sachdev et al randomly assigned 12 individuals to receive right or left dorsolateral prefrontal stimulation 10 Hz110 resting motor threshold 15 minutes 5 sessionsweek for 2 weeks Subjects showed significant improvement at two weeks and 1-month follow-up regardless of lateralit A randomized controlled trial comparing right prefrontal stimulation to sham treatment in 18 OCD subjects was negative however low frequency 1 Hz stimulation was used in contrast to previous reports 110 motor threshold 20 minutes 3 timesweek for 6 weeks Most recently a small study of 10 individuals with OCD andor Tourettes syndrome found benefit with low-frequency stimulation of the supplementary motor area 1 Hz 100 motor threshold 20 minutes 5 sessionsweek for 2 weeks Notably subjects were treatment-resistant in both this and the Sachdev study Thus although this limited literature precludes any definitive conclusions it suggests that rTMS may be of benefit in refractory OCD
In this study we propose to investigate the effectiveness of rTMS treatment in refractory OCD Although ideal treatment parameters need to be established the above literature suggests that high frequency stimulation of the dorsolateral prefrontal cortex is likely to be beneficial Bilateral stimulation will be used our previous work has demonstrated this method to be safe and well tolerated Moreover patients will be assigned in randomized double-blind fashion to receive either active or sham TMS allowing for more definitive conclusions to be drawn We also propose to explore whether the induction of CI mediates the therapeutic effects of rTMS on OCD symptoms
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