tSCS and AR Training on QoL and Physical Activity in Diabetic Neuropathy Patients

Official title

Combined Effects of Transcutaneous Spinal Cord Stimulation (tSCS) and Augmented Reality (AR) Training on Quality of Life (QoL) and Physical Activity in Diabetic Neuropathy Patients

Overview

Existing evidence of tSCS emphasizes pain relief and overlooks other functional parameters such as sensory enhancement, lower limb flexibility, and sustained improvements in physical activity and QoL. Combined effects of tSCS and AR training on lower limb flexibility, vibration sense, QoL, and physical activity in patients with diabetic neuropathy. This dual approach has the potential to deliver a comprehensive strategy for managing DPN, which is low-cost, safe, and a more accessible solution for diabetic patients in Pakistan and around the world.

Detailed description

Pakistan has seen a rise in diabetes prevalence, 26.7% among adults, with 43.16% developing neuropathy. This high prevalence is associated with significant complications. Approximately 15% of these cases can progress to limb amputation, which severely impacts QoL, increases dependence on caregivers, and imposes long-term psychosocial and economic stress on patients and their families.

Transcutaneous spinal cord stimulation (tSCS) is a noninvasive neuromodulation technique that involves the application of electrical stimuli over the thoracic or lumbar spinal cord regions. Studies suggest that tSCS may influence afferent sensory pathways, potentially improving vibration perception and proprioceptive feedback, particularly at 30Hz, resulting in enhanced QoL.

Augmented reality (AR)-based rehabilitation has also emerged as a non-invasive tool to enhance balance, postural control, and motor learning in patients with diabetic neuropathy. Recent studies support the use of immersive AR environments in improving lower limb flexibility, gait, and functional performance in neuropathy patients, thus increasing their QoL.

Interventions

• Other Transcutaneous spinal cord stimulation Group
  Transcutaneous spinal cord stimulation will be administered non-invasively using surface electrodes placed over the D12-L1 spinal segment. Stimulation will be delivered using the Soterix 1×1 Transcutaneous Electrical Stimulation (TES) unit. Stimulation will be applied at a frequency range of 30 Hz. The pulse duration is 1 ms, and the intensity will be set at 2 mA. A ramp-up and ramp-down time of 30 seconds will be used to enhance participant comfort during the start and end of each stimulation s
• Other Augmented reality
  AR-based rehabilitation will involve interactive balance and coordination tasks performed in a virtual environment all while receiving real-time visual feedback to guide movement accuracy and postural control. The main training block will comprise exercises focusing on hip flexion, hip abduction, knee flexion, and lateral weight shifting. Each module will be performed for 5-8 minutes, with short rest intervals between tasks.

Primary outcome measures

• International Physical Activity Questionnaire [Time frame: Up to week 5]
• Diabetes Quality of Life Questionnaire [Time frame: Up to week 5]

Secondary outcome measures (2)

• Neurothesiometer [Time frame: Up to week 5]
• Sit and reach test [Time frame: Up to week 5]

Eligibility criteria

Inclusion criteria

• More than or equals to 4 scores on Douleur Neuropathique 4 Questionnaire (DN4)
• More than or equals to 6 Hz at Neurothesiometer

Exclusion criteria

• Cognitively compromised (MOCA score ≤ 26/30)
• Metallic implants at skull
• Shunting
• Skin allergy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639. PMID 35160091
• Mekhail NA, Argoff CE, Taylor RS, Nasr C, Caraway DL, Gliner BE, Subbaroyan J, Brooks ES. High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials. 2020 Jan 15;21(1):87. doi: 10.1186/s13063-019-4007-y. PMID 31941531
• Stanica IC, Moldoveanu F, Portelli GP, Dascalu MI, Moldoveanu A, Ristea MG. Flexible Virtual Reality System for Neurorehabilitation and Quality of Life Improvement. Sensors (Basel). 2020 Oct 23;20(21):6045. doi: 10.3390/s20216045. PMID 33114272
• Alonso-Enriquez L, Gomez-Cuaresma L, Billot M, Garcia-Bernal MI, Benitez-Lugo ML, Casuso-Holgado MJ, Luque-Moreno C. Effectiveness of Virtual Reality and Feedback to Improve Gait and Balance in Patients with Diabetic Peripheral Neuropathies: Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Nov 24;11(23):3037. doi: 10.3390/healthcare11233037. PMID 38063604

Identifiers

NCT: NCT07619755 · REC02260 Fatima Zahra

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗