tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy

NCT07619794 | Not Yet Recruiting

• 1 other identifier: REC02262 Mahnoor Imtiaz
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

tSCS and AR-based training have individually shown benefits in neuromotor rehabilitation; no study to date has evaluated their combined effects on pain, balance, lower-limb strength, retention, and vibration sense in diabetic neuropathy. The rationale for combining them lies in their complementary mechanisms: tSCS at 30 Hz activates large-diameter Aβ afferents, inhibiting nociceptive input, enhancing spinal excitability, and facilitating motor activation.

Conditions

Diabetic Neuropathies

Keywords

Spinal cord stimulation; diabetic peripheral neuropathy; pain; balance

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  The Numeric Pain Rating Scale (NPRS) is a quick, 11-point measure (0 = no pain to 10 = worst imaginable) commonly used across clinical and research settings. Recent studies demonstrate test-retest reliability ranging from 0.58 to 0.93 (good to excellent), with moderate evidence for a minimal clinically important difference (MCID) of 1.5-2.5 points.

  Up to week 5 (baseline/week 1/week 5)

• Time Up and Go (TUG)

  The TUG test is a simple, clinically validated tool used to assess dynamic balance and functional mobility. It requires an individual to rise from a seated position, walk three meters, turn, return, and sit down. The TUG demonstrated excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging from 0.89 to 0.94 across multiple trials.

  Up to week 5 (Baseline/week 1/week 5)

Secondary Outcomes (2)

• 30 Second Chair Stand Test

  Up to week 5 (Baseline/week 1/week 5)

• Neurothesiometer

  Up to week 5 (Baseline/Week 1/week 5)

Study Arms (3)

Transcutaneous spinal cord stimulation and Augmented Reality Group

EXPERIMENTAL

Other: transcutaneous spinal cord stimulation; Other: Augmented Reality

Augmented Reality Group

ACTIVE COMPARATOR

Other: Augmented Reality

Transcutaneous spinal cord stimulation Group

ACTIVE COMPARATOR

Other: transcutaneous spinal cord stimulation

Interventions

transcutaneous spinal cord stimulation OTHER

Transcutaneous spinal cord stimulation will be administered non-invasively using surface electrodes placed over the D12-L1 spinal segment. This segmental level has been shown to effectively engage lower-limb motor and sensory networks across multiple spinal segments. 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. Pulse duration of 1 ms, and 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 session, following standardized electrode placement and safety protocols.

Transcutaneous spinal cord stimulation Group; Transcutaneous spinal cord stimulation and Augmented Reality Group

Augmented Reality OTHER

AR-based rehabilitation will consist of interactive balance and coordination tasks conducted in a virtual environment, with real-time visual feedback provided to guide movement accuracy and postural control. The core training block will include five structured modules: interactive kicking exercises to promote ankle and knee coordination; color-target foot-reaching tasks to enhance proprioception and reaction time; virtual obstacle navigation to improve gait and stepping control; static and dynamic balance challenges, such as maintaining posture on virtual planks; and lower-limb strengthening activities, including squats and stepping-based games. Each module will be performed for 5-8 minutes, with brief rest periods between tasks.

Augmented Reality Group; Transcutaneous spinal cord stimulation and Augmented Reality Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than or equals to 4 score on Douleur Neuropathique 4 Questionnaire
• More than or equals to 6 Hz at Neurothesiometer
• More than or equals to 4 score on the Numeric Pain Rating Scale (NPRS)

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (5)

• Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.

  PMID: 33818600 BACKGROUND

• Lamichhane P, Sukralia S, Alam B, Shaikh S, Farrukh S, Ali S, Ojha R. Augmented reality-based training versus standard training in improvement of balance, mobility and fall risk: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Jun 20;85(8):4026-4032. doi: 10.1097/MS9.0000000000000986. eCollection 2023 Aug.

  PMID: 37554880 BACKGROUND

• Henson JV, Varhabhatla NC, Bebic Z, Kaye AD, Yong RJ, Urman RD, Merkow JS. Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy: A Systematic Review. Pain Ther. 2021 Dec;10(2):895-908. doi: 10.1007/s40122-021-00282-9. Epub 2021 Jul 10.

  PMID: 34244979 BACKGROUND

• Strand NH, Burkey AR. Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. J Diabetes Sci Technol. 2022 Mar;16(2):332-340. doi: 10.1177/19322968211060075. Epub 2021 Nov 29.

  PMID: 34842478 BACKGROUND

• Gylfadottir SS, Christensen DH, Nicolaisen SK, Andersen H, Callaghan BC, Itani M, Khan KS, Kristensen AG, Nielsen JS, Sindrup SH, Andersen NT, Jensen TS, Thomsen RW, Finnerup NB. Diabetic polyneuropathy and pain, prevalence, and patient characteristics: a cross-sectional questionnaire study of 5,514 patients with recently diagnosed type 2 diabetes. Pain. 2020 Mar;161(3):574-583. doi: 10.1097/j.pain.0000000000001744.

  PMID: 31693539 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahnoor Imtiaz, DPT

CONTACT

0092 315 5214237; mahnoorimtiaz54@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: June 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)