Title : Repetitive transcranial magnetic stimulation in new daily persistent headache patients: A single arm open label study
Abstract:
New daily persistent headache (NDPH) is a challenging condition to treat, characterized by a continuous and unremitting headache from onset. Traditional pharmacological treatments for NDPH often yield suboptimal results, prompting the exploration of novel therapeutic approaches. Transcranial magnetic stimulation (TMS) has emerged as a promising non-invasive neuromodulatory technique for various types of headaches, including migraine.
Aim of the study: To evaluate the efficacy of repetitive transcranial magnetic stimulation for reduction in headache frequency and severity in NDPH patients.
This open label prospective, single arm, interventional pilot study was conducted at tertiary care center in Northern India between October2022 to September 2023. Eligible subjects participated in a run-in period where they were instructed to record their pain on a visual analogue scale of 0 to 10 in a diary daily for one month (4 weeks) and headache disability assessed by Headache Impact test (HIT-6) questionnaires with a score ranging from 36-78, to ensure an adequate baseline for comparison. Subjects were also screened for depression, anxiety and somatic symptom disorder by DSM-V criteria. Participants subsequently received active three days sessions of 10 Hz repetitive transcranial magnetic stimulation (RTMS) comprising of 600 pulses in 10 trains, delivered to left frontal cortex. The primary outcome was defined by 50% reduction in headache severity based on VAS score and number of headache free days at the end of 4 weeks. The secondary outcome was based on impact on functional disability based on HIT-6 questionnaire. A reduction in HIT -6 score of ≥6 was considered significant.
Results: A total of 50 participants who met the inclusion criteria (mean [SD] age 35.06[13.91] years; 31 [62%] female) were included in this study. 5[10%] patients could remember the exact date of onset, 31[62%] patients could remember the month and 14[28%] subjects could not remember the onset. 5[10%] patients had generalized anxiety disorder and 16[32%] had depression and 21[42%] had somatic symptom disorder. 35 patients [70 %] had an improvement in VAS score of ≥50 percent at the end of 4 weeks (p value<0.001). The mean headache free days at the end of 4 weeks was (mean [SD] )10.84[4.88] days. A reduction in HIT-6 score of ≥6 was seen in 38 [76%] patients (p- value <0.001). Minor adverse effects were noted in 2 patients [4 %] in the form of sound intolerance.
Conclusion: The study suggests that repetitive transcranial magnetic stimulation by modulating cortical excitability and neuroplasticity holds promise as a potentially effective and well-tolerated intervention for new daily persistent headache patients. To the best of our knowledge, this is the first study employing RTMS treatment for NDPH patients, however our study requires external validation in a placebo-controlled, large cohort study with longer follow up period.
Audience Take Away Notes:
- New daily persistent headache is a rare clinical entity characterized by continuous and unremitting headache not accounted by any other diagnosis, often refractory to traditional pharmacological treatment.
- Higher prevalence of mood disorders in patients of NDPH when compared to the general population.
- RTMS can be a promising treatment option with good safety profile for patients with NDPH, however external validation is required from further studies.
