Clinical trial NCT04897425: Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities
Official title: Mindful SensoriMotor Therapy With Brain Modulation for the Treatment of Pain in Individuals With Disarticulation or Nerve Injuries: A Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Phantom Limb Pain
Keywords: Guided Plasticity therapy
Phantom Motor Execution
Mindful SensoriMotor Therapy
Brain Modulation
transcranial Direct Current Stimulation (tDCS)
Neurological disorders
Neurobehavioral Manifestations
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2021-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm clinical trial
Primary purpose: TREATMENT

Brief summary: Brief summary: This single-arm, pilot clinical investigation aims to evaluate Mindful SensoriMotor Therapy (MSMT) enhanced with brain modulation as a treatment of pain due to sensorimotor impairment, such as Phantom Limb Pain (PLP). MSMT consists of consciously retraining the motor and sensory networks used by the missing limb via myoelectric pattern recognition and haptic feedback. In this trial, we further enhance the effect of MSMT by brain modulation, transcranial Direct Current Stimulation (tDCS).

Detailed description: People with upper or lower limb disarticulation (amputation at joint level) or nerve injury will participate in this study. It is a single-arm study in which all participants receive the same intervention. Each participant attends a screening visit, up to 5 baseline assessments, 15 interventions, and 3 follow-ups at 1, 3, and 6 months after the last intervention. Brain imaging will be performed pre- and post-treatment.

Eligibility criteria: Inclusion criteria

* The participant has given written informed consent to participate.
* The participant must have chronic neuropathic pain due to sensorimotor impairment (example PLP).
* At least six months should be passed since the date of injury (acute pain cases should not be included in the study).
* If the participant is under pharmacological treatments, there must be no variations on the medication dosages (steady consumption) for at least 1 month before the screening visit.
* If the participant has previously been treated for neuropathic pain, the last session of that treatment(s) must be at least 3 months before the screening visit.
* Any pain reduction potentially correlated to previous neuropathic pain treatments must have been observed at least 3 months prior to the screening visit, as reported by the participant.
* In the case of having a prosthesis, the participant must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis or not using a prosthesis).
* Participants must have enough contact surface at the site of the amputation or the injured nerves for the system to work, in the researcher's opinion.
* Participants must be able to perceive the haptic stimulation at the time of the screening visit.
* Participants must not experience painful sensations from haptic stimulation in the stump (i.e. allodynia).
* The participant has a sufficient understanding of both Swedish and English to be able to participate in all study assessments, in the researcher's opinion.
* Participants should not have any other condition or symptoms that can prevent them from participating in the study, in the researcher's opinion.
* No mental inability, reluctance, or language difficulties that result in difficulty understanding the meaning of study participation, in the researcher's opinion.
* The participant should not have any condition associated with the risk of poor protocol compliance, in the researcher's opinion.

Exclusion criteria

- The potential participant will be excluded from the study if the person does not meet at least one of the inclusion criteria.

Primary outcomes:
measure: The change in Pain Rating Index (PRI) over the treatment duration
timeFrame: Pain Rating Index registered at the beginning and at the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.]
Secondary outcomes:
measure: The change in Pain Disability Index (PDI) between the first and the last treatment session.
timeFrame: PDI assessed at the beginning the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.]
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Center for Bionics and Pain Research, CBPR
state: Västra Götaland
Study officials:
affiliation: Associate Professor
name: Max Ortiz Catalan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.
citation: Lendaro E, Hermansson L, Burger H, Van der Sluis CK, McGuire BE, Pilch M, Bunketorp-Kall L, Kulbacka-Ortiz K, Rigner I, Stockselius A, Gudmundson L, Widehammar C, Hill W, Geers S, Ortiz-Catalan M. Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Jul 16;8(7):e021039. doi: 10.1136/bmjopen-2017-021039.
citation: Ortiz-Catalan M. The Stochastic Entanglement and Phantom Motor Execution Hypotheses: A Theoretical Framework for the Origin and Treatment of Phantom Limb Pain. Front Neurol. 2018 Sep 6;9:748. doi: 10.3389/fneur.2018.00748. eCollection 2018.