Teta Burst Versus 10 Hz Repetitive Transcranial Magnetic Stimulation İn Neuropathic Pain: A Sham Controlled Comparison

NCT06197113 | Completed

• 1 other identifier: AnkaraCHBilkent_ozgearar
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Neuropathic pain is a common complication after spinal cord injury (SCI), which significantly affects the patient's quality of life and may be resistant to pharmacological treatment. In our study, we aimed to evaluate the efficacies of intermittent theta burst (iTBS) and high frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) by comparing them with each other and with sham stimulation, in the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI. Question 1: İs rTMS anda iTBS treatment, useful for pain severity and the effect of pain on daily functions, in the treatment of neuropathic pain in SCI Question 2: Are rTMS and iTBS treatments effective in depression in patients with neuropathic pain after spinal cord injury?

Conditions

Neuropathic Pain

Keywords

Repetitive Transcranial Magnetic Stimulation; Intermittent Teta Burst Stimulation; Spinal cord injury; Depression; Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain severity and pain interference assessed using the Brief Pain Inventory-Short Form (BPI-SF)

  Brief Pain Inventory-Short Form (BPI-SF) is designed to assess pain in sensory (pain intensity and severity) and reactive dimensions (impact on daily functioning). The BPI-SF consists of two sections. The first section evaluates the intensity of worst, least, average, and current pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates no pain at all quot; and a response of 10 indicates pain as bad as you can imagine. The second section consists of seven questions that assess the impact of pain on general activity, mood, work, walking ability, sleep, relationships with others, and enjoyment of life. Responses are rated on a scale of 0 to 10. A response of 0 in the second section indicates 'does not interfere' and a response of 10 indicates 'completely interferes'. The second section total score is calculated by summing the scores of the seven questions, resulting in a score out of 70. The total score ranges from 0 to 70.

  Patients were evaluated with BPI-SF before the treatment, at the end of the treatment (within the first 24 hours after the 10th session) and 4 weeks after the end of the treatment.

Secondary Outcomes (3)

• Change in depression severity assessed using the Beck Depression Inventory (BDI)

  Patients were evaluated with BDI before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.

• Patient-reported treatment satisfaction assessed using a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied)

  It was administered immediately after the end of treatment and 4 weeks after the end of treatment.

• Treatment-related discomfort assessed using a 10-cm Visual Analog Scale (VAS; 0 = no discomfort, 10 = worst imaginable discomfort)

  It was administered immediately after the end of treatment.

Study Arms (3)

10 Hz rTMS group

ACTIVE COMPARATOR

To the patients in the high frequency (10 Hz) rTMS (n:9) group, 110% resting motor threshold (rMT), 10 Hz frequency stimulation, 5-second stimulation, and then a total of 30 trains and 1500 pulses at 25-second intervals were applied for 15 minutes while targeting the lower extremity motor area.

Device: Magstim Rapid2 Magnetic Stimulator

iTBS group

ACTIVE COMPARATOR

To the patients in iTBS group (n:9), three bursts of stimulation at 50 Hz, repeated every 200 milliseconds, were delivered for 2 seconds every 10 seconds, totaling 600 stimuli at MT intensity, applied for a duration of 200 seconds.10 sessions was applied while targeting the lower extremity motor area.

Device: Magstim Rapid2 Magnetic Stimulator

Sham Group

SHAM COMPARATOR

The patients in the sham group (n:8) were given sham stimulation with a sham coil for 10 sessions.

Device: Magstim Rapid2 Magnetic Stimulator

Interventions

Magstim Rapid2 Magnetic Stimulator DEVICE

For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.

10 Hz rTMS group; Sham Group; iTBS group

Eligibility Criteria

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

You may qualify if:

• Between the ages of 18-65,
• Traumatic/Non-traumatic spinal cord injury (\>4 months),
• For \>3 months, despite pharmacological treatment (no dose or medication changes have been made for at least 1 month), Brief Pain Inventory (BPI)-Part 1 average pain score is ≥4/10, neuropathic pain at the injury level and/or below (DN4 ≥4 /10) patients

You may not qualify if:

• Pain attributed to causes other than neuropathic pain (e.g. musculoskeletal pain, pain resulting from diabetic polyneuropathy), Having a history of epilepsy, dementia, cognitive impairment, neurodegenerative disease,
• Having a history of psychiatric illness (except reactive depression),
• Having a lesion in the brain due to vascular, traumatic, tumoral or infectious reasons,
• Having a history of alcoholism,
• Having an intracranial metallic implant,
• Having a cardiac pacemaker,
• Pregnant patients

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (9)

• Siddall PJ. Management of neuropathic pain following spinal cord injury: now and in the future. Spinal Cord. 2009 May;47(5):352-9. doi: 10.1038/sc.2008.136. Epub 2008 Nov 11.

  PMID: 19002150 BACKGROUND

• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

  PMID: 31901449 BACKGROUND

• Andre-Obadia N, Magnin M, Garcia-Larrea L. Theta-burst versus 20 Hz repetitive transcranial magnetic stimulation in neuropathic pain: A head-to-head comparison. Clin Neurophysiol. 2021 Oct;132(10):2702-2710. doi: 10.1016/j.clinph.2021.05.022. Epub 2021 Jun 20.

  PMID: 34217600 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Yildirim Y, Parlar Kilic S, Eyigor S, Eyigor C, Yildirim Y, Karaman E, Oyur Celik G, Uyar M. Validity and reliability of Turkish version of the Brief Pain Inventory-Short Form for patients with chronic nonmalignant pain. Agri. 2019 Nov;31(4):195-201. doi: 10.14744/agri.2019.25901.

  PMID: 31741339 BACKGROUND

• Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239.

  PMID: 9636945 BACKGROUND

• Herwig U, Satrapi P, Schonfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003 Winter;16(2):95-9. doi: 10.1023/b:brat.0000006333.93597.9d.

  PMID: 14977202 BACKGROUND

• Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.

  PMID: 12849236 BACKGROUND

• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

  PMID: 15664172 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries; Depression; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: July 1, 2022
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: April 1, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)