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Postdural Puncture HeadacheNCT06640634

Effect of Anodal Transcranial Direct Current Stimulation on Postdural Puncture Headache

A study testing active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS) and active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS) in people with Postdural Puncture Headache and Lumbar Puncture, run by Neuromed IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Postdural Puncture Headache, Lumbar Puncture
What is being tested?
active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS) and active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
1 siteItaly
Study dates
11 Jan 2022to 23 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Neuromed

    Pozzilli, Isernia, 86077

Other trials in Italy

About this study

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

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.

Read more

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.

Being 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)
Keywords
headache, post-dural puncture headache, transcranial direct current stimulation, noninvasive brain stimulation, neuromodulation
Medical subject headings
Post-Dural Puncture Headache, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06640634
Study groupRoleWhat they receive
therapeutic a-tDCS (Th-tDCS)ExperimentalIn patients diagnosed with PDPH, three consecutive days of active a-tDCS intervention are performed starting from the day of diagnosis.
Receives: Device: active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
sham in therapeutic t-DCS (Th-tDCS)Sham comparatorIn patients diagnosed with PDPH, three consecutive days of sham a-tDCS are performed starting from the day of diagnosis
Receives: Device: sham in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
preventive a-tDCS (Pr-tDCS)ExperimentalPatients undergoing a lumbar puncture for diagnostic purposes receive an active a-tDCS intervention for three consecutive days.
Receives: Device: active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)
sham in preventive tDCS (Pr-tDCS)Sham comparatorPatients undergoing a lumbar puncture for diagnostic purposes receive an sham tDCS for three consecutive days.
Receives: Device: sham in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From enrollment to the end of treatment at 1 week

Secondary outcomes (1)

  1. Brief Pain Inventory (BPI)

    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).

    Measured: From enrollment to the end of treatment at one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start11 Jan 2022
  3. Primary completion11 Apr 2024
  4. Study completion23 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06640634
Sponsor's protocol ID
PDPH-tDCS
Status last verified
Oct 2024
First submitted
8 Oct 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ornello R, Caponnetto V, Ratti S, D'Aurizio G, Rosignoli C, Pistoia F, Ferrara M, Sacco S, D'Atri A. Which is the best transcranial direct current stimulation protocol for migraine prevention? A systematic review and critical appraisal of randomized controlled trials. J Headache Pain. 2021 Nov 27;22(1):144. doi: 10.1186/s10194-021-01361-0.

    PubMed 34837963

  • Dasilva AF, Mendonca ME, Zaghi S, Lopes M, Dossantos MF, Spierings EL, Bajwa Z, Datta A, Bikson M, Fregni F. tDCS-induced analgesia and electrical fields in pain-related neural networks in chronic migraine. Headache. 2012 Sep;52(8):1283-95. doi: 10.1111/j.1526-4610.2012.02141.x. Epub 2012 Apr 18.

    PubMed 22512348

  • Auvichayapat P, Janyacharoen T, Rotenberg A, Tiamkao S, Krisanaprakornkit T, Sinawat S, Punjaruk W, Thinkhamrop B, Auvichayapat N. Migraine prophylaxis by anodal transcranial direct current stimulation, a randomized, placebo-controlled trial. J Med Assoc Thai. 2012 Aug;95(8):1003-12.

    PubMed 23061303

  • Cerrahoglu Sirin T, Aksu S, Hasirci Bayir BR, Ulukan C, Karamursel S, Kurt A, Baykan B. Is Allodynia a Determinant Factor in the Effectiveness of Transcranial Direct Current Stimulation in the Prophylaxis of Migraine? Neuromodulation. 2021 Jul;24(5):899-909. doi: 10.1111/ner.13409. Epub 2021 May 31.

    PubMed 34058041

  • De Icco R, Putorti A, De Paoli I, Ferrara E, Cremascoli R, Terzaghi M, Toscano G, Allena M, Martinelli D, Cosentino G, Grillo V, Colagiorgio P, Versino M, Manni R, Sances G, Sandrini G, Tassorelli C. Anodal transcranial direct current stimulation in chronic migraine and medication overuse headache: A pilot double-blind randomized sham-controlled trial. Clin Neurophysiol. 2021 Jan;132(1):126-136. doi: 10.1016/j.clinph.2020.10.014. Epub 2020 Nov 5.

    PubMed 33271482

  • Meeker TJ, Keaser ML, Khan SA, Gullapalli RP, Seminowicz DA, Greenspan JD. Non-invasive Motor Cortex Neuromodulation Reduces Secondary Hyperalgesia and Enhances Activation of the Descending Pain Modulatory Network. Front Neurosci. 2019 May 8;13:467. doi: 10.3389/fnins.2019.00467. eCollection 2019.

    PubMed 31139047

  • Naegel S, Biermann J, Theysohn N, Kleinschnitz C, Diener HC, Katsarava Z, Obermann M, Holle D. Polarity-specific modulation of pain processing by transcranial direct current stimulation - a blinded longitudinal fMRI study. J Headache Pain. 2018 Oct 24;19(1):99. doi: 10.1186/s10194-018-0924-5.

    PubMed 30355321

  • Lefaucheur JP. Pain. Handb Clin Neurol. 2013;116:423-40. doi: 10.1016/B978-0-444-53497-2.00035-8.

    PubMed 24112914

  • Fregni F, El-Hagrassy MM, Pacheco-Barrios K, Carvalho S, Leite J, Simis M, Brunelin J, Nakamura-Palacios EM, Marangolo P, Venkatasubramanian G, San-Juan D, Caumo W, Bikson M, Brunoni AR; Neuromodulation Center Working Group. Evidence-Based Guidelines and Secondary Meta-Analysis for the Use of Transcranial Direct Current Stimulation in Neurological and Psychiatric Disorders. Int J Neuropsychopharmacol. 2021 Apr 21;24(4):256-313. doi: 10.1093/ijnp/pyaa051.

    PubMed 32710772

  • Lefaucheur JP. Cortical neurostimulation for neuropathic pain: state of the art and perspectives. Pain. 2016 Feb;157 Suppl 1:S81-S89. doi: 10.1097/j.pain.0000000000000401.

    PubMed 26785160

  • Knotkova H, Hamani C, Sivanesan E, Le Beuffe MFE, Moon JY, Cohen SP, Huntoon MA. Neuromodulation for chronic pain. Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7.

    PubMed 34062145

  • Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.

    PubMed 12949224

  • Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

    PubMed 27866120

  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PubMed 10990547

  • Arévalo-Rodríguez I, Ciapponi A, Munoz L, et al (2011) Posture and fluids for preventing post-dural puncture headache. In: Arévalo-Rodríguez I (ed) Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd, Chichester, UK

Questions about this trial

What is this clinical trial studying?

A study testing active in therapeutic tDCS (Th-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS) and active in preventive tDCS (Pr-tDCS): anodal transcranial Direct Current Stimulation (a-tDCS) in people with Postdural Puncture Headache and Lumbar Puncture, run by Neuromed IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) (time frame: From enrollment to the end of treatment at 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06640634, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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