Back to resultsrTMS for the Treatment of Neuropathic Pain in Diabetic Patients
Primary Purpose
Neuropathic Pain, Diabetic Neuropathies
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
rTMS
Sham rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria: Written informed consent to participate in this study is obtained The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2 The patient has laboratory-confirmed diabetes Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings A score of > /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain. The patient has a painful diabetic neuropathy for at least 6 months The patient has a Numeric pain rating scale (NPRS) score >/= 4. The patient is resistant to standard therapies for neuropathic pain Exclusion Criteria: The patient has an implanted cardiac device, such as a pacemaker or a defibrillator The patient has an implanted neurostimulator The patient has cochlear implants/ear implants, magnetic dental im-plants The patient has a drug infusion pump The patient has cerebral artery aneurysm clips The patient has a history of epilepsy The patient has a history of migraine or severe headaches The patient has significant psychiatric disorders For female patients: the subject is pregnant or lactating Other formal contra-indication for rTMS or MRI
Sites / Locations
- University hospital Brussels
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active rTMS
Sham rTMS
Arm Description
The patient will receive one daily rTMS session for 5 days of HF-rTMS, delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s
Sham stimulation will be delivered using a sham coil.
Outcomes
Primary Outcome Measures
Changes in pain severity
Neuropathic pain rating scale; Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable
Changes in functional connectivity of the M1 with brain areas involved in pain processing
rs-fMRI will be used
Changes in brain metabolism
MRS will be used
Changes in brain plasticity
Paired-pulse stimulation will be used
Secondary Outcome Measures
Influence on the quality of life
RAND 36-Item Health Survey; It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. A high score defines a more favorable health state.
influence on depression
Beck Depression Inventory (BDI-II); total scores ranging from 0 to 63. Higher total scores indicate more severe depressive symptoms
influence on nerve conduction
Electrodiagnostic testing: This involves nerve conduction studies (NCS) and electromyography (EMG) testing.
During NCS the following measurements will be performed:
Motor conduction of the peroneal nerve, median motor study
sensory conduction of the sural nerves, median and ulnar nerve
Soleus H-reflex
Sympathic skin respons
EMG study of distal and proximal muscles of at least one upper and lower extremity will be performed.
Full Information
NCT ID
NCT05792072
First Posted
December 7, 2022
Last Updated
March 17, 2023
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05792072
Brief Title
rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
Official Title
High Frequency rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients.
This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients.
Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli.
One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Diabetic Neuropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active rTMS
Arm Type
Active Comparator
Arm Description
The patient will receive one daily rTMS session for 5 days of HF-rTMS, delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham stimulation will be delivered using a sham coil.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
High-frequency rTMS
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
sham rTMS
Primary Outcome Measure Information:
Title
Changes in pain severity
Description
Neuropathic pain rating scale; Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable
Time Frame
The NPRS will be controlled at following time points: prior to the initiation of the rTMS protocol, and then weekly until 2 months after the last treatment.
Title
Changes in functional connectivity of the M1 with brain areas involved in pain processing
Description
rs-fMRI will be used
Time Frame
rs-fMRI will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Title
Changes in brain metabolism
Description
MRS will be used
Time Frame
MRS will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Title
Changes in brain plasticity
Description
Paired-pulse stimulation will be used
Time Frame
Paired-pulse stimulation will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Secondary Outcome Measure Information:
Title
Influence on the quality of life
Description
RAND 36-Item Health Survey; It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. A high score defines a more favorable health state.
Time Frame
Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Title
influence on depression
Description
Beck Depression Inventory (BDI-II); total scores ranging from 0 to 63. Higher total scores indicate more severe depressive symptoms
Time Frame
Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Title
influence on nerve conduction
Description
Electrodiagnostic testing: This involves nerve conduction studies (NCS) and electromyography (EMG) testing.
During NCS the following measurements will be performed:
Motor conduction of the peroneal nerve, median motor study
sensory conduction of the sural nerves, median and ulnar nerve
Soleus H-reflex
Sympathic skin respons
EMG study of distal and proximal muscles of at least one upper and lower extremity will be performed.
Time Frame
this wil be controlled at baseline and 2 months after the last treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent to participate in this study is obtained
The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2
The patient has laboratory-confirmed diabetes
Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings
A score of > /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain.
The patient has a painful diabetic neuropathy for at least 6 months
The patient has a Numeric pain rating scale (NPRS) score >/= 4.
The patient is resistant to standard therapies for neuropathic pain
Exclusion Criteria:
The patient has an implanted cardiac device, such as a pacemaker or a defibrillator
The patient has an implanted neurostimulator
The patient has cochlear implants/ear implants, magnetic dental im-plants
The patient has a drug infusion pump
The patient has cerebral artery aneurysm clips
The patient has a history of epilepsy
The patient has a history of migraine or severe headaches
The patient has significant psychiatric disorders
For female patients: the subject is pregnant or lactating
Other formal contra-indication for rTMS or MRI
Facility Information:
Facility Name
University hospital Brussels
City
Brussels
State/Province
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
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rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
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