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Behavioural Intervention

TMS for Neuropathic Pain

N/A
Recruiting
Led By Julian C Motzkin, MD/PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable on chronic pain medications for 4 weeks prior to the study and agreeable to continue throughout the study. These medications include: Tricyclic antidepressants (e.g., nortriptyline, amitriptyline), SNRIs (e.g., duloxetine, venlafaxine), gabapentinoids (e.g., gabapentin, pregabalin), antiepileptics (e.g., valproic acid, carbamazepine, lamotrigine), and daily anti-inflammatories (e.g., meloxicam), among others (as determined by study physician at the time of screening). Note: Medications that are known to increase cortical excitability (e.g., buproprion, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., antiepileptics, benzodiazepines, and atypical antipsychotics), or any other medications with relative hazard for use in TMS will be allowed upon review of medications and/or motor threshold determination by TMS specialist
"Pain caused by a lesion or disease of the somatosensory nervous system
Must not have
Females who are pregnant or nursing
Procedural: prior rTMS within 1 year of consent, enrollment in other clinical trial in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate whether non-invasive magnetic pulses to the brain can reduce chronic neuropathic pain, which is highly disabling and challenging to treat.

Who is the study for?
This trial is for adults aged 18-80 with chronic neuropathic pain lasting over 6 months due to nerve damage or disease. Participants must have a certain level of continuous pain, be able to tolerate the procedures, and give informed consent. They should be stable on their current pain medications and not pregnant, nursing, or have specific psychiatric conditions or contraindications for TMS.
What is being tested?
The study tests high frequency rTMS versus low frequency rTMS as treatments for chronic neuropathic pain. It aims to determine if stimulating the brain's motor cortex can reduce pain by modulating brain activity without the side effects common in other treatments.
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Some individuals might experience temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on the same pain medication for 4 weeks and can continue during the study.
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I have pain due to nerve damage or disease.
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I experience ongoing pain in my face or limbs.
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I am between 18 and 80 years old.
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I understand and can agree to the study's procedures and risks.
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My pain is due to nerve damage or disease.
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I have been experiencing severe pain for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or nursing.
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I haven't had rTMS or been in a clinical trial in the last 6 months.
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I am unable to commit to the full duration of the study.
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I have not had major psychiatric disorders, thoughts of suicide, brain surgery, or electroconvulsive therapy.
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I do not have any unstable health conditions like heart disease or uncontrolled high blood pressure.
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I don't have metal implants in my head, uncontrolled movements, or conditions increasing seizure risk.
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I do not have severe memory problems, speech issues, seizures, specific brain conditions, or complete paralysis where treatment is targeted.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pain Intensity Over 2 weeks
Secondary study objectives
Change in Beck Depression Inventory (BDI-II) Scores
Pain
Change in Pain Intensity Over 6 months
+4 more
Other study objectives
Brain Network Assessment
Change Pittsburgh Sleep Quality Index (PSQI) Scores
Heart rate
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Frequency rTMSExperimental Treatment1 Intervention
High frequency 10 Hz stimulation of motor cortex (M1)
Group II: Low Frequency rTMSActive Control1 Intervention
Low frequency 1 Hz stimulation of motor cortex (M1)

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,156 Total Patients Enrolled
2 Trials studying Neuropathic Pain
121 Patients Enrolled for Neuropathic Pain
Julian C Motzkin, MD/PhDPrincipal InvestigatorUniversity of California, San Francisco
Prasad Shirvalkar, MD/PHDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

High Frequency rTMS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05593237 — N/A
Neuropathic Pain Research Study Groups: High Frequency rTMS, Low Frequency rTMS
Neuropathic Pain Clinical Trial 2023: High Frequency rTMS Highlights & Side Effects. Trial Name: NCT05593237 — N/A
High Frequency rTMS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05593237 — N/A
~1 spots leftby Dec 2024
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