Mental Representation Techniques for the Treatment of Parkinson´s Disease-related Pain

NCT ID: NCT04651478

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2021-12-31

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.

Conditions

Parkinson Disease; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Action Observation+Motor Imagery through BCI

Action Observation+Motor Imagery through a Brain-Computer Interface training paradigm in Virtual Reality using the "NeuRow" platform during 10 sessions of 20 minutes, divided in 4 series of 5 minutes.

Group Type: EXPERIMENTAL

Action Observation+Motor Imagery through BCI

Intervention Type: BEHAVIORAL

Patients will undergo the treatment through the NeuRow platform. NeuRow is a gamified Brain-Computer Interface training paradigm in Virtual Reality (or neurogame) that allows patients to perform the same actions as they would do in real-life by imaging the movement. In NeuRow, patients will see a boat and two high fidelity virtual arms gripping two oars in the first-person view. Patients will have to imagine the movement of each corresponding hand to rotate each oar and progress, observing the movement imagined on screen. The goal of the task is to collect as many flags as possible in a fixed amount of time. In order to improve adherence, the number of flags collected will be recorded in each session. It will be able to adapt the boat speed, turn speed, and cut-off angle, to help patients not to deviate in excess from the target. The treatment itself will be performed for 20 minutes each session, divided into 4 series of 5 minutes to prevent fatigue.

Action Observation through non-related with movement illustrations

Control Action Observation protocol of non-related with movement illustrations during 10 sessions of 20 minutes, divided in 4 series of 5 minutes.

Group Type: PLACEBO_COMPARATOR

Action Observation through non-related with movement illustrations

Intervention Type: BEHAVIORAL

The same configuration will be applied to simulate a BCI task, but playing a video about graphic illustrations, people's faces, and landscapes, never related to human movement. They will address interesting and changing topics to avoid patient's boredom. The control session will last 20 minutes, also divided into 4 series of 5 minutes and the therapist will give the instructions of observing and relax.

Interventions

Action Observation+Motor Imagery through BCI

Patients will undergo the treatment through the NeuRow platform. NeuRow is a gamified Brain-Computer Interface training paradigm in Virtual Reality (or neurogame) that allows patients to perform the same actions as they would do in real-life by imaging the movement. In NeuRow, patients will see a boat and two high fidelity virtual arms gripping two oars in the first-person view. Patients will have to imagine the movement of each corresponding hand to rotate each oar and progress, observing the movement imagined on screen. The goal of the task is to collect as many flags as possible in a fixed amount of time. In order to improve adherence, the number of flags collected will be recorded in each session. It will be able to adapt the boat speed, turn speed, and cut-off angle, to help patients not to deviate in excess from the target. The treatment itself will be performed for 20 minutes each session, divided into 4 series of 5 minutes to prevent fatigue.

Intervention Type: BEHAVIORAL

Action Observation through non-related with movement illustrations

The same configuration will be applied to simulate a BCI task, but playing a video about graphic illustrations, people's faces, and landscapes, never related to human movement. They will address interesting and changing topics to avoid patient's boredom. The control session will last 20 minutes, also divided into 4 series of 5 minutes and the therapist will give the instructions of observing and relax.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Beata María Ana

OTHER

Sponsor Role: collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Pablo Romero Muñoz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales

Josue Fernández Carnero, PT PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

Locations

Hospital Beata María Ana

Madrid, , Spain

Countries

Spain

Central Contacts

Juan Pablo Romero Muñoz, MD PhD

Role: CONTACT

p.romero.prof@ufv.es

+34917091400 ext. 1688

Facility Contacts

Juan Pablo Romero Muñoz, MD. PhD.

Role: primary

p.romero.prof@ufv.es

+34917091400 ext. 1688

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Other Identifiers

PainPD-Imagine

Identifier Type: -

Identifier Source: org_study_id