Clinical trial NCT04651478: Mental Representation Techniques for the Treatment of Parkinson´s Disease-related Pain
Official title: Mental Representation Techniques Targeting Pain in Parkinson´s Disease Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Pain
Keywords: Parkinson Disease
Pain
Action Observation
Motor Imagery
Virtual Reality
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: Hospital Beata María Ana
name: Universidad Rey Juan Carlos
First posted: 2020-12-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a double-blinded experimental longitudinal prospective randomized controlled trial with a parallel design. The randomization will be realized through randomization software. All the participants who fulfill the inclusion criteria and have none of the exclusion ones will be randomly allocated into two groups: AO+MI through a Brain-Computer Interface (BCI) training paradigm in Virtual Reality (VR) (AO+MI-BCI) or AO of non-related with movement illustrations (AO-control). Allocation concealment will be ensured by the inclusion of the assigned group in closed opaque envelopes that will be opened at the time of the intervention.
Primary purpose: TREATMENT

Brief summary: Pain is an under-reported but prevalent symptom in Parkinson´s Disease (PD), impacting patients' quality of life. Both pain and PD conditions cause cortical excitability reduction, but mental representations techniques are thought to be able to counteract it, resulting also effective in chronic pain conditions. The investigators of the present project aim to evaluate the efficacy of a novel mental representation protocol in the management of pain in PD patients during the ON state. The investigators hypothesize that Action Observation (AO) and Motor Imagery (MI) training through a Brain-Computer Interface (BCI) using Virtual Reality (AO+MI-BCI) can improve clinical pain and its central processing features.

Detailed description: Parkinson´s Disease (PD) affects between 4.1 and 4.6 million people in the world. The diagnosis of PD is currently clinical and based on its motor manifestations (bradykinesia, rest tremor, and rigidity). However, non-motor symptoms such as pain, fatigue, and neuropsychiatric manifestations are present in more than 70% of subjects. Pain affects about 85% of patients but is paradoxically under-reported and consequently under-treated in PD patients with a great impact on their quality of life. Levodopa, which is the election treatment in PD, has shown controversial results regarding pain sensitivity and has been shown ineffective for enhancing the endogenous pain modulation system. Furthermore, there is a lack of management protocols and nonpharmacologic treatments for pain in PD. Several syndromes are hypothesized to be involved in PD pain generation. Generally, PD patients suffer from alterations in peripheral transmission, sensitive-discriminative processing, pain perception, and pain interpretation in multiple levels, due to neurodegenerative changes in dopaminergic pathways and non-dopaminergic pain-related structures. Therefore, central mechanisms are proposed to be crucial for the development and establishment of pain in PD patients. Regarding pain processing features, PD patients have reduced pain thresholds, an augmented Temporal Summation (TS) after repetitive nociceptive stimulus, and the impairment of their Conditioned Pain Modulation (CPM) is correlated with greater severity and premature onset of the disease. Cortical excitability reduction is common in patients with pain. Therefore, diverse therapies are being developed to counteract this cortical excitability reduction and obtaining, consequently, effective pain relief. In consonance with these findings, in PD condition, especially in off state, there is also evidence of cortical excitability decrease but, to the best of investigators´ knowledge, there are no studies targeting cortical excitability to treat pain in PD. Thus, the present study proposes mental representation techniques for the treatment of PD-related pain. The mental representation techniques included in the protocol will be Action Observation (AO) and Motor Imagery (MI). The combination of AO and MI has shown to synergically increase cortical excitability, influencing the activation of cortical areas such as M1 and DLPFC. Specifically in PD, AO and MI have also demonstrated to produce corticomotor facilitation. In addition, mental representation training can produce neurophysiological activity similar to actual exercise training, which has shown to decrease the intensity and severity of pain in PD patients. The main aim of this study is to conduct an independent parallel randomized controlled trials based on AO+MI-BCI targeting changes in 1. validated general and specific PD related pain scales and 2. psychophysical measurements of pain modulation mechanisms. The investigators´ main hypothesis is that AO+MI-BCI will be superior to their respective control placebo intervention.

Eligibility criteria: Inclusion Criteria:

* Neuroimaging study without previous pathologies.
* Score \> 5 in transfers (bed to chair and back) item in Barthel Index.
* Score = or \> 24 in Mini-Mental State Examination.
* Able to provide informed consent to participate in the study.

Exclusion Criteria:

* History of neurologic disease different from PD.
* Presence of non-related to PD pain.
* Dermatologic problems, wounds, or ulcers in the electrode's application area.
* Significative difficulties in language.
* History of alcohol or drugs abuse.
* Non-controlled medical problems.
* Pregnancy.

Primary outcomes:
measure: Change in King´s Parkinson´s Disease Pain Scale score
timeFrame: From Baseline at 2 weeks
measure: Change in King´s Parkinson´s Disease Pain Scale score
timeFrame: From Baseline at 1 month
measure: Change in Brief Pain Inventory score
timeFrame: From Baseline at 2 weeks
measure: Change in Brief Pain Inventory score
timeFrame: From Baseline at 1 month
measure: Change in Conditioned Pain Modulation
timeFrame: From Baseline at 2 weeks
measure: Change in Conditioned Pain Modulation
timeFrame: From Baseline at 1 month
measure: Change in Temporal Summation
timeFrame: From Baseline at 2 weeks
measure: Change in Temporal Summation
timeFrame: From Baseline at 1 month
measure: Changes in Pain Pressure Threshold
timeFrame: From Baseline at 2 weeks
measure: Changes in Pain Pressure Threshold
timeFrame: From Baseline at 1 month
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: At 2 weeks from Baseline
measure: Beck Depression Inventory
timeFrame: At 1 month from Baseline
measure: State-Trait Anxiety Inventory
timeFrame: Baseline
measure: State-Trait Anxiety Inventory
timeFrame: At 2 weeks from Baseline
measure: State-Trait Anxiety Inventory
timeFrame: At 1 month from Baseline
measure: Tampa Scale of Kinesiophobia
timeFrame: Baseline
measure: Tampa Scale of Kinesiophobia
timeFrame: At 2 weeks from Baseline
measure: Tampa Scale of Kinesiophobia
timeFrame: At 1 month from Baseline
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: At 2 weeks from Baseline
measure: Pain Catastrophizing Scale
timeFrame: At 1 month from Baseline
measure: Unified Parkinson´s Disease Rating Scale
timeFrame: Baseline
measure: Unified Parkinson´s Disease Rating Scale
timeFrame: At 2 weeks from Baseline
measure: Unified Parkinson´s Disease Rating Scale
timeFrame: At 1 month from Baseline
measure: Reaction Times
timeFrame: Baseline
measure: Reaction Times
timeFrame: At 2 weeks from Baseline
measure: Reaction Times
timeFrame: At 1 month from Baseline
measure: Transcranial Magnetic Stimulation
timeFrame: Baseline
measure: Transcranial Magnetic Stimulation
timeFrame: At 2 weeks from Baseline
measure: Transcranial Magnetic Stimulation
timeFrame: At 1 month from Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Beata María Ana
Study officials:
affiliation: Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
name: Juan Pablo Romero Muñoz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Rey Juan Carlos
name: Josue Fernández Carnero, PT PhD
role: PRINCIPAL_INVESTIGATOR
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