Neuropathic Pain, Spinal Cord Injury
Conditions
Brief summary
The aim of this study is to evaluate the efficacy of rTMS targeting the anterior cingulate cortex, another stimulation site that may be effective in the treatment of neuropathic pain, and to compare it with motor cortex stimulation.
Interventions
DEVICEactive TMS
Patients in the active or sham primary motor cortex rTMS group will receive active or sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks. Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision.
DEVICEsham TMS
Patients in the active or sham primary motor cortex rTMS group will receive active or sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks. Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients for whom at least 12 months have passed since the date of the event 2. Patients who meet the International Pain Working Group's criteria for central neuropathic pain below the level of the lesion and who have had pain for at least 6 months 3. Patients aged 18-65 4. Pain not attributable to other causes such as rheumatological diseases or diabetes 5. Patients with VAS \> 4 despite maximum dose of pharmacological agents (anticonvulsants, antidepressants, narcotics), exercise and physical therapy agents, taking into account renal function tests and other comorbidities
Exclusion criteria
1. History of epilepsy 2. Metallic implant in the scalp 3. Cochlear implant 4. Spinal cord stimulator 5. Pacemaker 6. Presence of psychiatric illness 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale | first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment | The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time. The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neuropathic pain scale | first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment | — |
| Beck Depression Scale | first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment | — |
| 5-point Likert scale | first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment | It is a 5-point Likert scale to be used for assessing patient satisfaction. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAyşe Naz Kalem Özgen, specialist
Outcome results
None listed