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NCT Number: NCT06640634

Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache

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.

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Secondary Lumbar Puncture Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 75 years;
  • indication to undergo diagnostic lumbar puncture LP.

Exclusion criteria

  • any prior exposure to brain stimulation;
  • contraindications to tDCS;
  • a previous diagnosis of migraine or chronic headache;
  • usage of preventive medication at the baseline assessment;
  • history of depression
  • obesity
  • multiple lumbar puncture LP attempts.
  • cognitive impairment

Treatment and study plan

active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)

Device

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.

sham in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)

Device

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

active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)

Device

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.

sham in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)

Device

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

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: From enrollment to the end of treatment at 1 week

    The primary outcome was to assess differences between the two groups in PDPH-related pain, evaluated using the Visual Analogue Scale (VAS) and referred to pain intensity at that specific moment. The VAS is a self administered scale in which patients indicate the intensity of pain experienced by selecting a point on a continuous line ranging from 0 to 100 mm, representing the absence of pain to the worst pain, respectively. This scale is widely used in pain studies, with demonstrated validity and reproducibility. In the Th-tDCS study, VAS was administered at T0, before starting tDCS, and two hours before and two hours after the tDCS sessions (T1, T2, T3, T4, and T5).

    In the Pr-tDCS study, VAS was administered each day at the end of tDCS sessions (T0, T1, and T2).

Secondary outcomes

  1. Brief Pain Inventory (BPI)

    Time frame: From enrollment to the end of treatment at one week

    As secondary outcome we analyzed the effects of tDCS on other pain-related symptoms associated with LP, evaluated using the Brief Pain Inventory (BPI). The BPI is a multidimensional measurement tool originally developed to assess the intensity and interference of pain in cancer patients. In this study, the BPI was used to assess painful symptoms associated with LP, evaluating both the intensity of pain and its interference with affective and activity aspects of the patient's daily life over the past 24 hours.

    In the Th-tDCS study, the BPI was collected before starting tDCS (T0) and two hours after the last tDCS stimulation (T5). In the Pr-tDCS study, the BPI was collected before starting tDCS (T0) and two hours after the last stimulation (T2).

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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