Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231095
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-07
Brief Title:
Does TMS Affect Neuroplasticity The Role of Brain-derived Neurotrophic Factor and Neuronal Cell Adhesion Molecules - an Intensive Clinical Protocol Among Patients With Obsessive-compulsive Disorders
Sponsor:
Wroclaw Medical University
Organization:
Wroclaw Medical University
Study Overview
Official Title:
Does TMS Affect Neuroplasticity The Role of Brain-derived Neurotrophic Factor and Neuronal Cell Adhesion Molecules - an Intensive Clinical Protocol Among Patients With Obsessive-compulsive Disorders
Status:
COMPLETED
Status Verified Date:
2024-01
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:
Patients expressing interest in participating will undergo psychiatric assessment to verify the diagnosis of treatment-resistant obsessive-compulsive disorder OCD assess symptom severity and exclude TMS contraindications The study involves a cycle of 35 continuous theta burst stimulations cTBS in the supplementary motor area SMA over 5 working days with 7 stimulation sessions each day lasting 40 seconds A 1-hour break between sessions will be observed and each session will comprise 600 pulses at 90 of the motor threshold intensity
Biochemical analysis of blood serum from 40 patients will be conducted at three time points in an open-label study with active TMS stimulation
T0 - before starting stimulation T1 - after completing stimulation T2 - 1 month after completing stimulation
Inclusion criteria Diagnosis of depression or OCD according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems ICD-10 criteria Hamilton Depression Rating Scale HAM-D score 16 points or Yale-Brown Obsessive Compulsive Scale Y-BOCS score 19 points age 18-70 years
Exclusion criteria Contraindications to TMS procedures lack of informed consent and documented persistent non-cooperation with treatment
Biochemical analysis of blood serum from 40 patients will be conducted at three time points in an open-label study with active TMS stimulation
T0 - before starting stimulation T1 - after completing stimulation T2 - 1 month after completing stimulation
Inclusion criteria Diagnosis of depression or OCD according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems ICD-10 criteria Hamilton Depression Rating Scale HAM-D score 16 points or Yale-Brown Obsessive Compulsive Scale Y-BOCS score 19 points age 18-70 years
Exclusion criteria Contraindications to TMS procedures lack of informed consent and documented persistent non-cooperation with treatment
Detailed Description:
Transcranial Magnetic Stimulation TMS is an accepted non-invasive method of neurostimulation Evidence has demonstrated that TMS allows for the reduction of depression symptoms and an increasing number of reports support its efficacy in reducing symptoms of obsessive-compulsive disorder OCD There is a limited body of clinical research available on the mechanisms of TMS action Neuroplasticity refers to the capacity of neural tissue to form new connections for the purpose of reorganization and adaptation Brain-Derived Neurotrophic Factor BDNF and Cell Adhesion Molecules CAM are markers of neuroplasticity BDNF influences transmission in both excitatory and inhibitory synapses enhancing neurotransmitter release in cholinergic and dopaminergic neurons According to the neurotrophic hypothesis stress may decrease BDNF levels Serum BDNF concentrations are reduced in untreated patients with depression and normalized by antidepressant treatment Neuronal CAMs are among the most prevalent proteins playing a crucial role in synaptic plasticity Various CAMs appear to interact with BDNF In depression both reduced BDNF levels and polysialylated PSA neuronal CAMs are observed Conversely the levels of Vascular Cell Adhesion Molecule-1 VCAM-1 and Intracellular Adhesion Molecule-1 ICAM-1 in depression are inversely correlated with BDNF
To address this gap the investiagators aimed to verify the hypothesis that TMS in OCD leads to symptom reduction by inducing neuroplasticity through
Comparing changes in BDNF and CAM protein concentrations after TMS stimulation in OCD patients before and after stimulation
Assessing the correlation between changes in BDNF and CAM concentrations and the reduction of psychopathological symptoms
Evaluating the predictive value of initial BDNF and CAM concentrations
Study assumptions and planned procedures
Patients expressing interest in participating will undergo psychiatric assessment to verify the diagnosis of treatment-resistant OCD assess symptom severity and exclude TMS contraindications The study involves a cycle of 35 cTBS stimulations in the supplementary motor area SMA over 5 working days with 7 TMS sessions each day lasting 40 seconds A 1-hour break between sessions will be observed and each session will comprise 600 pulses at 90 of the motor threshold intensity
Biochemical analysis of blood serum from 40 patients will be conducted at three time points in an open-label study with active TMS stimulation
T0 - before starting stimulation T1 - after completing stimulation T2 - 1 month after completing stimulation
Inclusion criteria Diagnosis of depression or OCD according to ICD-10 criteria Hamilton Depression Rating Scale HAM-D score 16 points or Yale-Brown Obsessive Compulsive Scale Y-BOCS score 19 points age 18-70 years
Exclusion criteria Contraindications to TMS procedures lack of informed consent and documented persistent non-cooperation with treatment
To address this gap the investiagators aimed to verify the hypothesis that TMS in OCD leads to symptom reduction by inducing neuroplasticity through
Comparing changes in BDNF and CAM protein concentrations after TMS stimulation in OCD patients before and after stimulation
Assessing the correlation between changes in BDNF and CAM concentrations and the reduction of psychopathological symptoms
Evaluating the predictive value of initial BDNF and CAM concentrations
Study assumptions and planned procedures
Patients expressing interest in participating will undergo psychiatric assessment to verify the diagnosis of treatment-resistant OCD assess symptom severity and exclude TMS contraindications The study involves a cycle of 35 cTBS stimulations in the supplementary motor area SMA over 5 working days with 7 TMS sessions each day lasting 40 seconds A 1-hour break between sessions will be observed and each session will comprise 600 pulses at 90 of the motor threshold intensity
Biochemical analysis of blood serum from 40 patients will be conducted at three time points in an open-label study with active TMS stimulation
T0 - before starting stimulation T1 - after completing stimulation T2 - 1 month after completing stimulation
Inclusion criteria Diagnosis of depression or OCD according to ICD-10 criteria Hamilton Depression Rating Scale HAM-D score 16 points or Yale-Brown Obsessive Compulsive Scale Y-BOCS score 19 points age 18-70 years
Exclusion criteria Contraindications to TMS procedures lack of informed consent and documented persistent non-cooperation with treatment
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