NCT06640634

Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache

Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache: Results of Two Randomized Sham - Controlled Trials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Neuromed IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Post-dural puncture headache (PDPH) is the most prevalent complication in patients undergoing diagnostic or therapeutic lumbar puncture (LP). The pathophysiology of PDPH is primarily attributed to the mechanical traction on pain-sensitive intracranial nerves (e.g., the upper cervical, 5th, 9th, and 10th cranial nerves) and vascular structures, mediated by persistent dural damage leading to cerebrospinal fluid (CSF) leakage and subsequent CSF pressure reduction. According to the International Classification of Headache Disorders 3rd edition (ICHD3), PDPH is classified as a headache subtype due to low CSF pressure. It typically manifests as an orthostatic headache within a few days post-LP, accompanied by symptoms such as neck pain, tinnitus, auditory changes, photophobia, and nausea. While PDPH usually resolves within 7-10 days, it can result in extended hospital stays and increased need for medication. The use of atraumatic needles is the most effective preventive measure for PDPH, though other commonly recommended practices such as bed rest, fluid administration, and caffeine have questionable efficacy. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) technique that applies low-voltage electrical currents through surface electrodes on the scalp. Depending on the stimulation type-anodal or cathodal-tDCS can induce long-lasting increases or decreases in neuronal excitability and vascular-neuronal activity coupling. Research has shown that anodal tDCS (a-tDCS) applied to the primary motor cortex (M1) can alleviate various pain conditions, including fibromyalgia, neuropathic pain, and headaches. The pain-relieving effects of M1 a-tDCS are believed to follow the modulation of intracortical inhibitory GABAergic transmission, and the descending connections from M1 to the thalamus and periaqueductal gray. Although short-term a-tDCS treatment has shown promise in preventing migraines and medication-overuse headaches, its role in preventing and treating PDPH remains unexplored. This study aims to evaluate the efficacy of preventive and therapeutic a-tDCS applied to M1 in patients undergoing diagnostic LP.

Conditions

• Postdural Puncture Headache
• Lumbar Puncture

Interventions

Type	Name	Description
DEVICE	active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)	Active in therapeutic tDCS (Th-tDCS) in patients diagnosed with PDPH. The stimulations were delivered using a battery-driven direct current stimulator (HDCstim-DC stimulator, Newronika S.r.l. Milano - Italy). The current was administered through a pair of saline-soaked surface electrodes. The anode, measuring 3x3 cm, was placed over the primary motor cortex (M1) in the dominant hemisphere. This location was identified using the International 10-20 EEG system for C3 (left M1) or C4 (right M1). The cathode, measuring 6x4 cm, was positioned over the contralateral supraorbital region, immediately below the Fp position. In the active a-tDCS groups, each session consisted of 20 minutes stimulation with a 2 mA intensity for 3 consecutive days.
DEVICE	sham in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)	Sham in therapeutic tDCS (Th-tDCS) in patients diagnosed with PDPH. In the sham tDCS groups, the duration and electrodes application were the same of active in therapeutic tDCS (Th-tDCS), but the current was stopped 30 s thereafter. The subject felt the initial itching sensation, but no changes in cortical excitability are produced
DEVICE	active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)	Active in preventive tDCS (Pr-tDCS) in patients who have undergone a lumbar puncture for diagnostic purposes. The stimulations were delivered using a battery-driven direct current stimulator (HDCstim-DC stimulator, Newronika S.r.l. Milano - Italy). The current was administered through a pair of saline-soaked surface electrodes. The anode, measuring 3x3 cm, was placed over the primary motor cortex (M1) in the dominant hemisphere. This location was identified using the International 10-20 EEG system for C3 (left M1) or C4 (right M1). The cathode, measuring 6x4 cm, was positioned over the contralateral supraorbital region, immediately below the Fp position. In the active a-tDCS groups, each session consisted of 20 minutes stimulation with a 2 mA intensity for 3 consecutive days.
DEVICE	sham in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)	Sham in preventive tDCS (Pr-tDCS) in patients who have undergone a lumbar puncture for diagnostic purposes. In the sham tDCS groups, the duration and electrodes application were the same of active in preventive tDCS (Pr-tDCS), but the current was stopped 30 s thereafter. The subject felt the initial itching sensation, but no changes in cortical excitability are produced

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-04-11
• Completion: 2024-04-23
• First posted: 2024-10-15
• Last updated: 2025-04-02

Locations

1 site across 1 country: Italy