Mechanistic Study of Personalized rTMS in Chronic Pain
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAalborg University
About this trial
Previous research has demonstrated that repetitive magnetic brain stimulation can be an effective adjunctive treatment for several conditions, including chronic pain. However, current stimulation protocols are typically standardized and do not account for individual variability in brain function. This uniform, one-size-fits-all approach results in only about 40% of patients experiencing meaningful clinical benefit, while the remainder show little to no improvement. To address this limitation, the present study will investigate how magnetic stimulation can be tailored to individuals with chronic pain. By analyzing each participant's brain signals prior to treatment, we aim to personalize stimulation parameters to better match individual neural characteristics and potentially enhance therapeutic outcomes. The design of this study builds directly on the findings of a previous clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of chronic pain (present most of the days for more than 3 months).
Pain with a mean pain intensity between 3-9 on a 0-10 pain scale (where 0 means no pain and 10 means the worst pain imaginable).
Speak and understand English or Danish
Disqualifiers
Pregnant or breastfeeding
Current uncontrolled major depression as the main diagnosis
Current history of substance abuse
Lack of ability to cooperate, to fully understand the protocol or any difficulty in filling out questionnaires (e.g., due to language or cognitive problems)
Trial design
Design model
Parallel
Treatments tested in this trial
Classical repetitive trancranial magnetic stimulation to M1
DeviceThe rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds with an interval of twenty seconds between trains will be delivered, as traditionally performed. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes.
Personalized Target Arm
DeviceThe rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds will be delivered with an interval of twenty seconds between trains. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. The rTMS will be delivered to the optimal target
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Active Comparator : Classical rTMSActive comparator 1 intervention
Group B: Experimental: Personalized Target ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity (Visual analogue scale)
The '0' represents 'no pain' at all, and '100' represents the 'worst possible pain' that the individual can imagine.
Time frame
Visual analogue scale will be assessed before treatment, after 2 months, and again after 3 months. Responders are those with ≥30% pain reduction at the end of maintenance compared to average pain intensity the week before baseline assessment.Secondary outcomes
1
Quality of life (EQ-5D)
Quality of life (EQ-5D) is a standardized measure of health-related quality of life. This is the value derived from the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The EQ-5D-5L is a scale from 0 to 100, where 100 is the best health imaginable.
Time frame
Quality of life changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.2
Patients' Global Impression of Change
The questionnaire assesses the individual's impression of change after an intervention. Minimum value: 1 = "Very much worse" and Maximum value: 7 = "Very much improved"
Time frame
Patients' Global Impression of Change will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment3
Short Brief Pain Inventory
9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning
Time frame
Short Brief Pain Inventory changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.4
Connectivity analysis
Electroencephalography recorded during single pulses of transcranial magnetic stimulation will be used to evaluate brain connectivity. Global mean field power, local mean field power, inter-trial coherence and event-related strectral perturbation will be the main outcome.
Time frame
Connectivity changes will be investigated before the treatment and immediately after 2 months of treatment.Sponsors and contacts
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Source ClinicalTrials.gov