Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache

Neuromed IRCCS

Status: Completed

Conditions: Postdural Puncture Headache; Lumbar Puncture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06640634

PDPH-tDCS

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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97 participants in 4 patient groups

therapeutic a-tDCS (Th-tDCS)

Experimental group

Description:

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

Treatment:

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

sham in therapeutic t-DCS (Th-tDCS)

Sham Comparator group

Description:

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

Treatment:

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

preventive a-tDCS (Pr-tDCS)

Experimental group

Description:

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

Treatment:

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

sham in preventive tDCS (Pr-tDCS)

Sham Comparator group

Description:

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

Treatment:

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