Mindful SensoriMotor Therapy combined with brain modulation for the treatment of pain in individuals with disarticulation or nerve injuries: a single-arm clinical trial

Shahrzad Damercheli; Mirka Buist; Max Ortiz-Catalan

doi:10.1136/bmjopen-2021-059348

Mindful SensoriMotor Therapy combined with brain modulation for the treatment of pain in individuals with disarticulation or nerve injuries: a single-arm clinical trial

BMJ Open. 2023 Jan 10;13(1):e059348. doi: 10.1136/bmjopen-2021-059348.

Authors

Shahrzad Damercheli^{1

2}, Mirka Buist^{1

3}, Max Ortiz-Catalan^{4

2

5

6}

Affiliations

¹ Center for Bionics and Pain Research, Mölndal, Sweden.
² Department of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden.
³ Department of Physiology, Institute of Physiology and Neuroscience, Sahlgrenska Academy, Gothenburg, Sweden.
⁴ Center for Bionics and Pain Research, Mölndal, Sweden maxo@chalmers.se.
⁵ Operational Area 3, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁶ Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Abstract

Introduction: Neuropathic pain is a complex and demanding medical condition that is often difficult to treat. Regardless of the cause, the impairment, lesion or damage to the nervous system can lead to neuropathic pain, such as phantom limb pain (PLP). No treatment has been found widely effective for PLP, but plasticity-guided therapies have shown the least severe side effects in comparison to pharmacological or surgical interventions. Phantom motor execution (PME) is a plasticity-guided intervention that has shown promising results in alleviating PLP. The potential mechanism underlying the effectiveness of PME can be explained by the Stochastic Entanglement hypothesis for neurogenesis of neuropathic pain resulting from sensorimotor impairment. We have built on this hypothesis to investigate the efficacy of enhancing PME interventions by using phantom motor imagery to facilitate execution and with the addition of sensory training. We refer to this new treatment concept as Mindful SensoriMotor Therapy (MiSMT). In this study, we further complement MiSMT with non-invasive brain modulation, specifically transcranial direct current stimulation (tDCS), for the treatment of neuropathic pain in patients with disarticulation or peripheral nerve injury.

Methods and analysis: This single-arm clinical trial investigates the efficacy of MiSMT and tDCS as a treatment of neuropathic pain resulting from highly impaired extremity or peripheral nerve injury in eight participants. The study consists of 12 sessions of MiSMT with anodal tDCS in the motor cortex, pretreatment and post-treatment assessments, and follow-up sessions (up to 6 months). The primary outcome is the change in pain intensity as measured by the Pain Rating Index between the first and last treatment sessions.

Ethics and dissemination: The study is performed under the approval of the governing ethical committee in Sweden (approval number 2020-07157) and in accordance with the Declaration of Helsinki.

Trial registration number: NCT04897425.

Keywords: clinical trials; neurological pain; pain management.

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Disarticulation
Humans
Motor Cortex*
Neuralgia* / therapy
Peripheral Nerve Injuries* / complications
Peripheral Nerve Injuries* / therapy
Phantom Limb* / therapy
Transcranial Direct Current Stimulation* / methods

Associated data

ClinicalTrials.gov/NCT04897425