Neuropathic PainbiTMSvsuniTMSNCT03710967
Bilateral TMS vs. Unilateral TMS
A study testing Transcranial magnetic stimulation in people with Neuropathic Pain and Orofacial Pain, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect compared to unilateral motor cortex stimulation by transcranial… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Orofacial Pain, Trigeminal Neuropathy
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from painful trigeminal neuropathy according to the International Classification of Headache Disorder (ICHD), 3rd beta version;
- Mean pain-intensity scores at baseline needed to be greater than 50mm as measured by the visual analogue scale (VAS);
- Aged between 18-80 years old;
- Non-pregnant, non-lactating and not planned to become pregnant during the study;
- Capable of completing headache pain self-assessments;
- Agrees not to change any medication or dosages in relation to the painful trigeminal neuropathy during the study
Who cannot join
- Patients were excluded from this study when they suffered from other neurological diseases (i.e., multiple sclerosis or epilepsy) or other chronic pain conditions or had a history of intracranial aneurysm, intracranial hemorrhage, brain tumor, or significant head trauma. Other exclusion criteria concerned patients having a pacemaker, intracardial device, neuromodulation device or other forms of metal implants in the craniocervical region. Finally, only patients who did not undergo any form of TMS prior to this experiment were included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral vs. Unilateral Transcranial Magnetic Stimulation of the Primary Motor Cortex to Treat Chronic Orofacial Pain: a Pilot Study With a Randomized Controlled Design
Rationale: In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect compared to unilateral motor cortex stimulation by transcranial magnetic stimulation.
Objective: To investigate the superiority of bilateral transcranial magnetic stimulation (TMS) over unilateral TMS of the motor cortex Study design: Double-blind, randomized controlled trial Study population: Patients that suffer from chronic orofacial pain and have not been treated (yet) with any form of neuromodulation.
Read more
Intervention (if applicable): One group receives bilateral TMS whereas the other group receives unilateral TMS for one month. After one month, the groups switch treatment protocol.
Main study parameters/endpoints: Modification in intensity of pain as measured using the VAS, the influence the relief of pain with regard to quality of life and daily activities using the McGill Pain Questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Time investment of patients.
Read the detailed description
For this study, we aim to include 12 patients with intractable, chronic orofacial pain of peripheral origin with a baseline VAS of at least 5 (0= no pain, 10= worst possible pain). The investigator (Dylan Henssen) contacts the pain nurse, neurosurgeons and pain physicians to ask them to seek contact with their patients to inform them about this research. Afterwards, if the patients wish to learn more or wish to participate, they receive an information package, including an information letter and an informed consent form. When the patient agrees to be included they receive four McGill Pain questionnaires which must be filled in weekly. After these four weeks, the patient is invited to the outpatient clinic to meet with the investigator. During this consultation, the patient talks about the pain he/she experiences, submits the four filled-in questionnaires and receives further information about the research. After the consultation, all patients are randomized in double-blinded fashion.
At the next meeting at the Donders Institute at Nijmegen, the patient takes place in a relaxing chair. A second, independent researcher will install the transcranial magnetic stimulation (TMS) coils, one on each side of the patient. The coils are positioned in such a fashion that both the coils can stimulate the primary motor cortex. Then the independent researcher starts the stimulation protocol. In the first session, the patient either receives unilateral or bilateral stimulation. After this session, the patient fills in a new McGill Pain questionnaire in order to measure the pain sensation after the first session of TMS. Then the patient goes home for one month. At home, another 4 McGill Pain Questionnaires are asked to fill in. After this, the patient returns to the Donders Institute to take place in the relaxing chair in order to be treated in the second session. Again, the patient either receives unilateral or bilateral stimulation, depending on what was received during the first session. Again, the patients are asked to fill in 4 new McGill Pain questionnaires, one per week (See figure 1).
At the end of this session, the patient is invited to meet with the investigator or independent researcher once more to talk about their experiences and pain relief during the research. This interview takes place at Radboudumc and is audio recorded.
All the McGill Pain questionnaires are analyzed by the researcher (Dylan Henssen) using SPSS. Afterwards, the independent researcher discloses which patient received uni- or bilateral in which order. The audio recorded interviews are transcribed verbatim and analyzed using Atlas.tii.
- Conditions
- Neuropathic Pain, Orofacial Pain, Trigeminal Neuropathy
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Neuralgia, Facial Pain, Trigeminal Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Transcranial magnetic stimulation of the primary motor cortex
| Study group | Role | What they receive |
|---|---|---|
| Bilateral TMS | Experimental | Not described Receives: Device: Transcranial magnetic stimulation |
| Unilateral TMS | Active comparator | Not described Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual analogue scale
Measured: 8 weeks
Secondary outcomes (3)
Medication intake
Medication quantification scale
Measured: 8 weeks
Quality of life
McGill Pain Questionnaire: Quality of life index
Measured: 8 weeks
Pain descriptor
McGill Pain Questionnaire: Pain descriptors
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 May 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single-blinded, randomized controlled cross-over design trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dylan Henssen, MD, Principal investigator, RadboudUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710967
- Sponsor's protocol ID
- NL62849.091.17
- Acronym
- biTMSvsuniTMS
- Status last verified
- Jun 2018
- First submitted
- 15 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral vs. Unilateral Transcranial Magnetic Stimulation of the Primary Motor Cortex to Treat Chronic Orofacial Pain: a Pilot Study With a Randomized Controlled Design
- ClinicalTrials.gov ID
- NCT03710967
- Acronym / sponsor ID
- biTMSvsuniTMS / NL62849.091.17
- Conditions
- Neuropathic Pain, Orofacial Pain, Trigeminal Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect compared to unilateral motor cortex stimulation by transcranial magnetic stimulation.
Objective: To investigate the superiority of bilateral transcranial magnetic stimulation (TMS) over unilateral TMS of the motor cortex Study design: Double-blind, randomized controlled trial Study population: Patients that suffer from chronic orofacial pain and have not been treated (yet) with any form of neuromodulation.
Intervention (if applicable): One group receives bilateral TMS whereas the other group receives unilateral TMS for one month. After one month, the groups switch treatment protocol.
Main study parameters/endpoints: Modification in intensity of pain as measured using the VAS, the influence the relief of pain with regard to quality of life and daily activities using the McGill Pain Questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Time investment of patients.
Detailed description
For this study, we aim to include 12 patients with intractable, chronic orofacial pain of peripheral origin with a baseline VAS of at least 5 (0= no pain, 10= worst possible pain). The investigator (Dylan Henssen) contacts the pain nurse, neurosurgeons and pain physicians to ask them to seek contact with their patients to inform them about this research. Afterwards, if the patients wish to learn more or wish to participate, they receive an information package, including an information letter and an informed consent form. When the patient agrees to be included they receive four McGill Pain questionnaires which must be filled in weekly. After these four weeks, the patient is invited to the outpatient clinic to meet with the investigator. During this consultation, the patient talks about the pain he/she experiences, submits the four filled-in questionnaires and receives further information about the research. After the consultation, all patients are randomized in double-blinded fashion.
At the next meeting at the Donders Institute at Nijmegen, the patient takes place in a relaxing chair. A second, independent researcher will install the transcranial magnetic stimulation (TMS) coils, one on each side of the patient. The coils are positioned in such a fashion that both the coils can stimulate the primary motor cortex. Then the independent researcher starts the stimulation protocol. In the first session, the patient either receives unilateral or bilateral stimulation. After this session, the patient fills in a new McGill Pain questionnaire in order to measure the pain sensation after the first session of TMS. Then the patient goes home for one month. At home, another 4 McGill Pain Questionnaires are asked to fill in. After this, the patient returns to the Donders Institute to take place in the relaxing chair in order to be treated in the second session. Again, the patient either receives unilateral or bilateral stimulation, depending on what was received during the first session. Again, the patients are asked to fill in 4 new McGill Pain questionnaires, one per week (See figure 1).
At the end of this session, the patient is invited to meet with the investigator or independent researcher once more to talk about their experiences and pain relief during the research. This interview takes place at Radboudumc and is audio recorded.
All the McGill Pain questionnaires are analyzed by the researcher (Dylan Henssen) using SPSS. Afterwards, the independent researcher discloses which patient received uni- or bilateral in which order. The audio recorded interviews are transcribed verbatim and analyzed using Atlas.tii.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single-blinded, randomized controlled cross-over design trial
| Arm | Type | Receives |
|---|---|---|
| Bilateral TMS | Experimental | Device: Transcranial magnetic stimulation |
| Unilateral TMS | Active comparator | Device: Transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suffering from painful trigeminal neuropathy according to the International Classification of Headache Disorder (ICHD), 3rd beta version;
- Mean pain-intensity scores at baseline needed to be greater than 50mm as measured by the visual analogue scale (VAS);
- Aged between 18-80 years old;
- Non-pregnant, non-lactating and not planned to become pregnant during the study;
- Capable of completing headache pain self-assessments;
Key exclusion criteria (1 listed)
- Patients were excluded from this study when they suffered from other neurological diseases (i.e., multiple sclerosis or epilepsy) or other chronic pain conditions or had a history of intracranial aneurysm, intracranial hemorrhage, brain tumor, or significant head trauma. Other exclusion criteria concerned patients having a pacemaker, intracardial device, neuromodulation device or other forms of metal implants in the craniocervical region. Finally, only patients who did not undergo any form of TMS prior to this experiment were included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationTranscranial magnetic stimulation of the primary motor cortex | Device | Bilateral TMS, Unilateral TMS |
Primary outcome
Pain intensity
Time frame: 8 weeks
Visual analogue scale
3 secondary outcomes
Medication intake
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Pain descriptor
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Henssen, MD principal investigator
RadboudUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Neuropathic Pain and Orofacial Pain, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.