NCT06640634

Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache

Completed NA Last updated 2 April 2025

What this trial tests

NA trial testing active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS) in Postdural Puncture Headache in 97 participants. Completed in 23 April 2024.

Timeline

11 January 2022

Primary endpoint
11 April 2024

23 April 2024

Quick facts

Lead sponsor	Neuromed IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	97
Start date	11 January 2022
Primary completion	11 April 2024
Estimated completion	23 April 2024
Sites	1 location across Italy

Drugs / interventions tested

• active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
• sham in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
• active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
• sham in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)

Conditions studied

• Postdural Puncture Headache — all drugs for Postdural Puncture Headache →
• Lumbar Puncture — all drugs for Lumbar Puncture →

Sponsor

Neuromed IRCCS

Who can join

Adults 18 to 75, any sex, with Postdural Puncture Headache or Lumbar Puncture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Anodal Transcranial Direct Current Stimulation on the Intensity of Post-dural Puncture Headache: Results of Two Randomized Sham Controlled Trials.
   Gjikolaj B, Stampanoni Bassi M, Bruno A, De Ioanni V, et al · · 2025 · cited 2× · PMID 40261600 · DOI 10.1007/s40120-025-00734-w