Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03761303
Status:
WITHDRAWN
Last Update Posted:
2019-12-17
First Post:
2018-11-30
Brief Title:
rTMS as an add-on Therapy in Patients With Post-stroke Depression
Sponsor:
BDH-Klinik Hessisch Oldendorf
Organization:
BDH-Klinik Hessisch Oldendorf
Study Overview
Official Title:
Investigation of the Efficacy of Repetitive Transcranial Magnetic Stimulation rTMS as an add-on Therapy in Patients With Post-stroke Depression PSD
Status:
WITHDRAWN
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No eligible patients could be recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
About 50 of all stroke patients develop post-stroke depression PSD A meta-analysis has shown that rTMS treatment can reduce depressive symptoms in PSD patients In addition to rTMS alone for the improvement of depression the question arises as to whether a combination therapy of rTMS plus antidepressant medication can achieve a stronger or longer-term effect in PSD patients Unfortunately there are currently no trials of combination therapy with rTMS and drug therapy in PSD patients Therefore this study will investigate whether combination therapy of antidepressant and rTMS can provide additional relief of depressive symptoms compared to antidepressant and sham rTMS therapy It is assumed that the additional active rTMS achieves a faster normalization of affect and drive than with a sham rTMS so that the patients benefit from neurorehabilitation measures earlier and more sustainably
Detailed Description:
Depression is one of the most common forms of mental illness According to studies by the World Health Organization WHO the World Bank and the European Brain Council 1 depression is the leading disease in Europe and Germany since the early 1990s
Besides drug or psychotherapeutic treatment repetitive transcranial magnetic stimulation rTMS is currently being used as a new non-invasive therapy for depression The rTMS applies an electromagnetic coil to the patients head creating a magnetic field Impulses emanating from the coil trigger a multitude of reactions at the point of stimulation which for example can alter the metabolism lead to a release of neurotransmitters and a change in gene expression 2-3 Pulses with a frequency 1Hz lead to a reduction of the excitability of the neurons and to an inhibition of cortical activity In contrast frequencies 5 Hz increase the excitability of neurons and increase cortical activity 4-5
A large number of studies has already shown that rTMS in depressive patients leads to an improvement in depressive symptoms and has been shown to have an antidepressant effect 6 In the United States rTMS has been approved by the Food and Drug Administration FDA since 2008 as a treatment for patients with depression who do not respond to antidepressant drug therapy The FDA recommends a high-frequency 10Hz rTMS on the left dorsolateral prefrontal cortex DLPFC five days a week for four to six weeks 7 The stimulation of the DLPFC is based on the valence hypothesis that the right hemisphere specializes in the processing of negative emotions and the left hemisphere is specialized in the processing of positive emotions 8 and the DLPFC controls emotional processing 9-10 Activation of the left DLPFC is therefore associated with the processing of positive emotions 11
About 50 of all stroke patients develop post-stroke depression PSD 12 A meta-analysis has shown that rTMS treatment can reduce depressive symptoms in PSD patients 13 In addition to rTMS alone it is unkown if a combination therapy of rTMS plus antidepressant medication can achieve a stronger or longer-term antidepressive effect in PSD patients Unfortunately there are currently no trials of combination therapy with rTMS and drug therapy in PSD patients Previous studies with depressive patients provide both results that suggest an additional effect of combination therapy 14-19 and results that found no difference between drug-only therapy and combination with rTMS 20-24 The comparability of the studies is difficult due to the heterogeneity of the study designs However it is noticeable that a younger age 50 years an intervention duration of rTMS of four weeks a higher dose of the antidepressant an inter-train interval interval between the trains of 30 seconds and a total number of pulses of 1250 per day associated with positive effects However further studies are needed that address the issue of an additional effect of combination therapy In addition a neurological disease was considered to be an exclusion criterion in some of the studies performed 14-15 20 23 It is therefore questionable whether the study results can be transferred to PSD patients
Therefore this study will investigate whether combination therapy of antidepressant and rTMS can provide additional relief of depressive symptoms compared to antidepressant and sham rTMS therapy It is assumed that the additional active rTMS achieves a faster normalization of affect and drive than with a sham rTMS so that the patients benefit from neurorehabilitation measures earlier and more sustainably
Besides drug or psychotherapeutic treatment repetitive transcranial magnetic stimulation rTMS is currently being used as a new non-invasive therapy for depression The rTMS applies an electromagnetic coil to the patients head creating a magnetic field Impulses emanating from the coil trigger a multitude of reactions at the point of stimulation which for example can alter the metabolism lead to a release of neurotransmitters and a change in gene expression 2-3 Pulses with a frequency 1Hz lead to a reduction of the excitability of the neurons and to an inhibition of cortical activity In contrast frequencies 5 Hz increase the excitability of neurons and increase cortical activity 4-5
A large number of studies has already shown that rTMS in depressive patients leads to an improvement in depressive symptoms and has been shown to have an antidepressant effect 6 In the United States rTMS has been approved by the Food and Drug Administration FDA since 2008 as a treatment for patients with depression who do not respond to antidepressant drug therapy The FDA recommends a high-frequency 10Hz rTMS on the left dorsolateral prefrontal cortex DLPFC five days a week for four to six weeks 7 The stimulation of the DLPFC is based on the valence hypothesis that the right hemisphere specializes in the processing of negative emotions and the left hemisphere is specialized in the processing of positive emotions 8 and the DLPFC controls emotional processing 9-10 Activation of the left DLPFC is therefore associated with the processing of positive emotions 11
About 50 of all stroke patients develop post-stroke depression PSD 12 A meta-analysis has shown that rTMS treatment can reduce depressive symptoms in PSD patients 13 In addition to rTMS alone it is unkown if a combination therapy of rTMS plus antidepressant medication can achieve a stronger or longer-term antidepressive effect in PSD patients Unfortunately there are currently no trials of combination therapy with rTMS and drug therapy in PSD patients Previous studies with depressive patients provide both results that suggest an additional effect of combination therapy 14-19 and results that found no difference between drug-only therapy and combination with rTMS 20-24 The comparability of the studies is difficult due to the heterogeneity of the study designs However it is noticeable that a younger age 50 years an intervention duration of rTMS of four weeks a higher dose of the antidepressant an inter-train interval interval between the trains of 30 seconds and a total number of pulses of 1250 per day associated with positive effects However further studies are needed that address the issue of an additional effect of combination therapy In addition a neurological disease was considered to be an exclusion criterion in some of the studies performed 14-15 20 23 It is therefore questionable whether the study results can be transferred to PSD patients
Therefore this study will investigate whether combination therapy of antidepressant and rTMS can provide additional relief of depressive symptoms compared to antidepressant and sham rTMS therapy It is assumed that the additional active rTMS achieves a faster normalization of affect and drive than with a sham rTMS so that the patients benefit from neurorehabilitation measures earlier and more sustainably
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