Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582355
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
FMRI-neurofeedback in Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MOTOR-NF - a Randomized Controlled Trial of FMRI-based Neurofeedback for Motor Symptoms of Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOTOR-NF
Brief Summary:
Rationale Current treatment of patients with Parkinsons disease PD is mainly based on the modulation of neural activity in the motor circuits of the basal ganglia and cerebral cortex by either drug intervention dopamine replacement therapy or dopaminergic medication or deep brain stimulation DBS However many Parkinson patients have an insufficient long-term response to medical treatments and DBS is an invasive procedure with resource implications and potential side effects Moreover not all patients are eligible for DBS Therefore new ways of administering neuromodulation are needed A potential avenue may be self-regulation of brain circuits through neurofeedback Self-regulation of motor circuits through mental imagery and neurofeedback using real-time functional MRI fMRI signals has already been shown to be feasible and there are also preliminary data on clinical benefits of such self-regulation training We here aim to use the non-invasive fMRI-neurofeedback method to train patients in the regulation of brain circuits that are implicated in successful drug treatment andor DBS
Objective To investigate brain mechanisms and efficacy of an fMRI-neurofeedback protocol that targets the brains motor circuits through the basal ganglia
Study design Randomised controlled trial Study population Patients with Parkinsons disease Investigation In the experimental group fMRI-neurofeedback will be administered in 4 separate sessions of about 2 hours each over approximately one month The MRI measurement in each session will be approximately 60 minutes long and include upregulation training of brain activity in specific target areas by mental imagery The fMRI signals are processed such that the patients get visual feedback about the success of the upregulation In addition patients are asked to practice the self-regulation strategies on a daily basis at home between the neurofeedback sessions The control intervention will consist of mental imagery without neurofeedback
Main study parametersendpoints Post-interventional improvement of motor symptoms of PD as assessed by the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS motor scale in the on-medication state
Nature and extent of the burden and risks associated with participation benefit and group relatedness This is a low-risk study where the main burden is participation time and MRI scans
Objective To investigate brain mechanisms and efficacy of an fMRI-neurofeedback protocol that targets the brains motor circuits through the basal ganglia
Study design Randomised controlled trial Study population Patients with Parkinsons disease Investigation In the experimental group fMRI-neurofeedback will be administered in 4 separate sessions of about 2 hours each over approximately one month The MRI measurement in each session will be approximately 60 minutes long and include upregulation training of brain activity in specific target areas by mental imagery The fMRI signals are processed such that the patients get visual feedback about the success of the upregulation In addition patients are asked to practice the self-regulation strategies on a daily basis at home between the neurofeedback sessions The control intervention will consist of mental imagery without neurofeedback
Main study parametersendpoints Post-interventional improvement of motor symptoms of PD as assessed by the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS motor scale in the on-medication state
Nature and extent of the burden and risks associated with participation benefit and group relatedness This is a low-risk study where the main burden is participation time and MRI scans
Detailed Description:
Parkinsons disease PD is associated with progressive neurodegeneration of dopaminergic neurons of the substantia nigra It is characterized by both motor and non-motor system manifestations Dopamine replacement therapy or dopaminergic medication are the key therapeutic strategies but deep brain stimulation DBS is increasingly being used in cases where drug response is has become insufficient or hampered by unacceptable side effects
Neurofeedback NF entails training of self-regulation of brain regions or networks via mental imagery and real-time feedback of neural signals for example obtained by functional MRI fMRI NF enables patients to develop personal strategies that are most effective in self-regulating brain areas and networks Thereby it can provide an individually tailored intervention NF is a highly sustainable form of non-invasive neuromodulation because once learnt the self-regulation strategies can in principle be applied by patients whenever needed to overcome disease symptomology
NF can be used to train patients to change their brain activity in different directions or to modulate patterns of co-activation between regions Mental imagery of moving ones own body also called kinaesthetic imagery can potentially be used to improve motor functions and neuroplasticity in PD Kinaesthetic imagery is also a suitable strategy for increasing activation in the brains motor network and motor imagery training can be reinforced through combination with NF A NF paradigm involving upregulation training of motor areas through kinaesthetic imagery thus has good plausibility for PD The PIs group has shown proof-of-concept of such an fMRI-NF training targeting the supplementary motor area SMA in PD and has recently completed a feasibility study of fMRI-NF targeting the putamen in 12 PD patients NCT05627895 The aim of the current investigator-initiated study is to investigate the effects of putamen upregulation training on motor function and other outcome parameters in PD
Neurofeedback NF entails training of self-regulation of brain regions or networks via mental imagery and real-time feedback of neural signals for example obtained by functional MRI fMRI NF enables patients to develop personal strategies that are most effective in self-regulating brain areas and networks Thereby it can provide an individually tailored intervention NF is a highly sustainable form of non-invasive neuromodulation because once learnt the self-regulation strategies can in principle be applied by patients whenever needed to overcome disease symptomology
NF can be used to train patients to change their brain activity in different directions or to modulate patterns of co-activation between regions Mental imagery of moving ones own body also called kinaesthetic imagery can potentially be used to improve motor functions and neuroplasticity in PD Kinaesthetic imagery is also a suitable strategy for increasing activation in the brains motor network and motor imagery training can be reinforced through combination with NF A NF paradigm involving upregulation training of motor areas through kinaesthetic imagery thus has good plausibility for PD The PIs group has shown proof-of-concept of such an fMRI-NF training targeting the supplementary motor area SMA in PD and has recently completed a feasibility study of fMRI-NF targeting the putamen in 12 PD patients NCT05627895 The aim of the current investigator-initiated study is to investigate the effects of putamen upregulation training on motor function and other outcome parameters in PD
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