Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache

NCT06640634 | Completed

• 1 other identifier: PDPH-tDCS
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

headache; post-dural puncture headache; transcranial direct current stimulation; noninvasive brain stimulation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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).

  From enrollment to the end of treatment at 1 week

Secondary Outcomes (1)

• Brief Pain Inventory (BPI)

  From enrollment to the end of treatment at one week

Study Arms (4)

therapeutic a-tDCS (Th-tDCS)

EXPERIMENTAL

In patients diagnosed with PDPH, three consecutive days of active a-tDCS intervention are performed starting from the day of diagnosis.

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

sham in therapeutic t-DCS (Th-tDCS)

SHAM COMPARATOR

In patients diagnosed with PDPH, three consecutive days of sham a-tDCS are performed starting from the day of diagnosis

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

preventive a-tDCS (Pr-tDCS)

EXPERIMENTAL

Patients undergoing a lumbar puncture for diagnostic purposes receive an active a-tDCS intervention for three consecutive days.

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

sham in preventive tDCS (Pr-tDCS)

SHAM COMPARATOR

Patients undergoing a lumbar puncture for diagnostic purposes receive an sham tDCS for three consecutive days.

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

Interventions

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.

therapeutic a-tDCS (Th-tDCS)

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

sham in therapeutic t-DCS (Th-tDCS)

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.

preventive a-tDCS (Pr-tDCS)

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

sham in preventive tDCS (Pr-tDCS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

Location

Related Publications (19)

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  BACKGROUND

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  PMID: 40261600 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Unit

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: January 11, 2022
• Primary Completion: April 11, 2024
• Study Completion: April 23, 2024
• Last Updated: April 2, 2025

Record last verified: 2024-10

Locations

IT (1)