Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04897425
• Other study ID #: 2020-07147
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2022
• Source: Chalmers University of Technology
• Contact: Max Ortiz Catalan, PhD
• Phone: +46708461065
• Email: maxo[@]chalmers.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Phantom Limb
• Phantom Limb Pain

Intervention

Device:
• Mindful SensoriMotor Therapy Enhanced with Brain Modulation
Hardware and software for myoelectric pattern recognition and sensory training developed at the Center for Bionics and Pain Research. tES by Neuroelectrics

Locations

Country	Name	City	State
Sweden	Center for Bionics and Pain Research, CBPR	Mölndal	Västra Götaland

Sponsors (2)

Lead Sponsor	Collaborator
Chalmers University of Technology	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Lendaro E, Hermansson L, Burger H, Van der Sluis CK, McGuire BE, Pilch M, Bunketorp-Käll L, Kulbacka-Ortiz K, Rignér 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. — View Citation

Ortiz-Catalan M, Guðmundsdóttir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragnö 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Pain Rating Index (PRI) over the treatment duration	The Pain Rating Index (PRI) is calculated as the sum of 15 descriptors presented to the participant at the end of each intervention session. Descriptors are rated from 0 (no pain) to 3 (maximum pain) and therefore, the PRI is a number between 0 and 45. The higher PRI number, the greater pain the person feels	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	The change in Pain Disability Index (PDI) between the first and the last treatment session.	The Pain Disability Index (PDI) measures the impact of the pain on the ability of a person to participate in essential life activities. The PDI is the sum of 7 categories and each of the category rates between 0 and 10. Therefore, the index is comprised between 0 and 70. The higher the index the greater the person's disability due to pain is.	PDI assessed at the beginning the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.]