The Safety and Feasibility of tDCS Combined With Conservative Treatment for Cervicogenic Headaches

NCT05582616 | Completed

• 1 other identifier: REB22-0890
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Annually, up to 150,000 individuals are affected by cervicogenic headaches (CGH) in Canada with many of these cases being chronic. Current treatments for CGH are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial direct current stimulation (tDCS) and physiotherapy have a high degree of safety and have been studied as interventions for many other chronic pain conditions and headache disorders. We propose to study the feasibility and safety of tDCS alongside physiotherapy for CGH further in a randomized sham controlled trial.

Conditions

Cervicogenic Headache

Keywords

Transcranial Direct Current Stimulation; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• Feasibility of tDCS through recruitment rate, retention rate in the study, and adherence rates to both tDCS and exercise therapy.

  The feasibility of tDCS will be measured through the rate of participants contacted vs those actually enrolled (expected to be greater than 30%), through rate of those enrolled vs those completing 6-weeks of treatment (expected to be greater than 80% retained), and through rates of those who completed all 18 tDCS sessions in 6-weeks as well as the percentage of exercise therapy sessions completed within the 6-week study period (expected to be greater than 70% for both).

  To be assessed throughout the 6 weeks of treatment and at post-treatment follow-up.

• Safety of tDCS through adverse events and transient changes in adverse effects within each tDCS session.

  The safety of tDCS will primarily be measured through tracking rates of serious adverse effects (defined as events requiring medical attention), to be considered safe we expect 0 events of this nature to occur. Additionally, changes in safety questionnaire scores tracking transient within-session changes were considered. Safety questionnaires ask participants to rate commonly experienced symptoms from 0-100 (0= "Not occurring", 100 = "Most severe"). The symptoms assessed are itchiness, tingling, burning sensations, headache, fatigue, nausea, and mood difficulties.

  To be assessed throughout the 6 weeks of treatment up to the post-treatment follow-up.

• Craniocervical Flexion Test (CCFT)

  Fine motor control of neck muscles will be measured via the Craniocervical Flexion Test (CCFT).

  To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

Secondary Outcomes (13)

• European Quality of Life Five Dimension (EQ-5D)

  To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

• Headache Impact Test 6 (HIT-6)

  To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

• Headache Disability Index (HDI)

  To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

• Pain Catastrophizing Scale (PCS)

  To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

• PROMIS Pain Interference Scale

  To be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

Other Outcomes (2)

• Headache Diary

  To be completed 2 weeks prior to treatment, 2 weeks after treatment, 2 weeks prior to 6 week assessment, and 2 weeks prior to 12 week assessment for a total of 8 weeks.

• Exercise diary

  To be completed each day for the duration of treatment (6 weeks).

Study Arms (2)

Active tDCS with physiotherapy

EXPERIMENTAL

Patients will engage in a six-week treatment protocol with 3 sessions per week (18 treatments). This was chosen to minimize discomfort and ensure the number of sessions is consistent with previous migraine literature. The primary motor cortex (M1) will be the treatment target to reduce pain sensitivity and improve motor learning. M1 will be found through measurements of the head: the point halfway between the nasion and inion and halfway between the left and right tragus will be found, we will then move down 20% of the inter-tragi distance and place the anode there. The cathode will then be placed over the super orbital region. Each electrode will be held in place with a strap and will make as much contact with the skin as possible. tDCS will be delivered via two 35cm2 surface sponge electrodes at an intensity of 2mA in the active group.

Device: Transcranial Direct Current Stimulation

Sham tDCS with physiotherapy

SHAM COMPARATOR

In the sham condition, the number of sessions, placement of electrodes, and types of electrodes used will be the same, however, only a 30 second ramp up period will be administered to emulate active tDCS therapy. Patients will be able to hear the sounds of the device and will feel slight tingling for the first 30 seconds but will receive no active stimulation. Previous sham studies have demonstrated efficacy of the blinding method.

Device: Sham Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

See treatment arm description

Active tDCS with physiotherapy

Sham Transcranial Direct Current Stimulation DEVICE

See sham comparator arm description

Sham tDCS with physiotherapy

Eligibility Criteria

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

You may qualify if:

• Diagnosed with cervicogenic headaches based on International Headache Society Guidelines lasting greater than 12 weeks
• The International Headache Society Guidelines are as follows: A) Presence of a headache fulfilling criterion C; B) Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache; C) Evidence of causation demonstrated by at least two of the following: (a) Headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion; (b) Headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion; (c) Cervical range of motion is reduced and headache is made significantly worse by provocative maneuvers; (d) Headache is abolished following diagnostic blockade of a cervical structure or its nerve supply.
• Average pain score ≥ 4/10 and Neck Disability score ≥ 28/50

You may not qualify if:

• Known cervical spine pathology (such as tumours or fractures)
• Nerve root pain/sensory loss
• Muscular or joint inflammatory conditions
• Neurological or psychiatric conditions
• Undergone recent surgery (within prior year)
• Have contraindications to tDCS (metal or electronic implants in the brain/skull; metal or electronic implants in other sites on the body; surgical procedures involving the head or spinal cord; skin problems such as dermatitis, psoriasis or eczema; epilepsy or a previous convulsion/seizure; fainting spells or syncope; pregnancy or any chance of pregnancy; previous electrical or magnetic stimulation)

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (43)

• Langer L, Levy C, Bayley M. Increasing Incidence of Concussion: True Epidemic or Better Recognition? J Head Trauma Rehabil. 2020 Jan/Feb;35(1):E60-E66. doi: 10.1097/HTR.0000000000000503.

  PMID: 31246881 BACKGROUND

• Barnsley L, Lord S, Bogduk N. Whiplash injury. Pain. 1994 Sep;58(3):283-307. doi: 10.1016/0304-3959(94)90123-6. No abstract available.

  PMID: 7838578 BACKGROUND

• Sjaastad O, Fredriksen TA, Batnes J, Petersen HC, Bakketeig LS. Whiplash in individuals with known pre-accident, clinical neck status. J Headache Pain. 2006 Feb;7(1):9-20. doi: 10.1007/s10194-006-0270-x. Epub 2006 Feb 20.

  PMID: 16485074 BACKGROUND

• Lord SM, Barnsley L, Wallis BJ, Bogduk N. Third occipital nerve headache: a prevalence study. J Neurol Neurosurg Psychiatry. 1994 Oct;57(10):1187-90. doi: 10.1136/jnnp.57.10.1187.

  PMID: 7931379 BACKGROUND

• Lindblom U, Verrillo RT. Sensory functions in chronic neuralgia. J Neurol Neurosurg Psychiatry. 1979 May;42(5):422-35. doi: 10.1136/jnnp.42.5.422.

  PMID: 448382 BACKGROUND

• Becser N, Sand T, Pareja JA, Zwart JA. Thermal sensitivity in unilateral headaches. Cephalalgia. 1998 Dec;18(10):675-83; discussion 657. doi: 10.1046/j.1468-2982.1998.1810675.x.

  PMID: 9950624 BACKGROUND

• Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.

  PMID: 19747657 BACKGROUND

• Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.

  PMID: 11403743 BACKGROUND

• Dumas JP, Arsenault AB, Boudreau G, Magnoux E, Lepage Y, Bellavance A, Loisel P. Physical impairments in cervicogenic headache: traumatic vs. nontraumatic onset. Cephalalgia. 2001 Nov;21(9):884-93. doi: 10.1046/j.1468-2982.2001.00264.x.

  PMID: 11903282 BACKGROUND

• Manchikanti L, Pampati V, Kaye AD, Hirsch JA. Cost Utility Analysis of Cervical Therapeutic Medial Branch Blocks in Managing Chronic Neck Pain. Int J Med Sci. 2017 Oct 15;14(13):1307-1316. doi: 10.7150/ijms.20755. eCollection 2017.

  PMID: 29200944 BACKGROUND

• Frazer A, Williams J, Spittles M, Rantalainen T, Kidgell D. Anodal transcranial direct current stimulation of the motor cortex increases cortical voluntary activation and neural plasticity. Muscle Nerve. 2016 Nov;54(5):903-913. doi: 10.1002/mus.25143. Epub 2016 May 20.

  PMID: 27065472 BACKGROUND

• Rroji O, van Kuyck K, Nuttin B, Wenderoth N. Anodal tDCS over the Primary Motor Cortex Facilitates Long-Term Memory Formation Reflecting Use-Dependent Plasticity. PLoS One. 2015 May 21;10(5):e0127270. doi: 10.1371/journal.pone.0127270. eCollection 2015.

  PMID: 25996937 BACKGROUND

• Zaninotto AL, El-Hagrassy MM, Green JR, Babo M, Paglioni VM, Benute GG, Paiva WS. Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. Dement Neuropsychol. 2019 Apr-Jun;13(2):172-179. doi: 10.1590/1980-57642018dn13-020005.

  PMID: 31285791 BACKGROUND

• Wessel MJ, Zimerman M, Hummel FC. Non-invasive brain stimulation: an interventional tool for enhancing behavioral training after stroke. Front Hum Neurosci. 2015 May 15;9:265. doi: 10.3389/fnhum.2015.00265. eCollection 2015.

  PMID: 26029083 BACKGROUND

• O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Apr 13;4(4):CD008208. doi: 10.1002/14651858.CD008208.pub5.

  PMID: 29652088 BACKGROUND

• Begemann MJ, Brand BA, Curcic-Blake B, Aleman A, Sommer IE. Efficacy of non-invasive brain stimulation on cognitive functioning in brain disorders: a meta-analysis. Psychol Med. 2020 Nov;50(15):2465-2486. doi: 10.1017/S0033291720003670. Epub 2020 Oct 19.

  PMID: 33070785 BACKGROUND

• Stilling JM, Monchi O, Amoozegar F, Debert CT. Transcranial Magnetic and Direct Current Stimulation (TMS/tDCS) for the Treatment of Headache: A Systematic Review. Headache. 2019 Mar;59(3):339-357. doi: 10.1111/head.13479. Epub 2019 Jan 23.

  PMID: 30671941 BACKGROUND

• Rahimi MD, Fadardi JS, Saeidi M, Bigdeli I, Kashiri R. Effectiveness of cathodal tDCS of the primary motor or sensory cortex in migraine: A randomized controlled trial. Brain Stimul. 2020 May-Jun;13(3):675-682. doi: 10.1016/j.brs.2020.02.012. Epub 2020 Feb 14.

  PMID: 32289696 BACKGROUND

• Andrade SM, de Brito Aranha REL, de Oliveira EA, de Mendonca CTPL, Martins WKN, Alves NT, Fernandez-Calvo B. Transcranial direct current stimulation over the primary motor vs prefrontal cortex in refractory chronic migraine: A pilot randomized controlled trial. J Neurol Sci. 2017 Jul 15;378:225-232. doi: 10.1016/j.jns.2017.05.007. Epub 2017 May 3.

  PMID: 28566169 BACKGROUND

• Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.

  PMID: 26852024 BACKGROUND

• Fernandez M, Moore C, Tan J, Lian D, Nguyen J, Bacon A, Christie B, Shen I, Waldie T, Simonet D, Bussieres A. Spinal manipulation for the management of cervicogenic headache: A systematic review and meta-analysis. Eur J Pain. 2020 Oct;24(9):1687-1702. doi: 10.1002/ejp.1632. Epub 2020 Jul 20.

  PMID: 32621321 BACKGROUND

• Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.

  PMID: 22460941 BACKGROUND

• Debarnot U, Neveu R, Samaha Y, Saruco E, Macintyre T, Guillot A. Acquisition and consolidation of implicit motor learning with physical and mental practice across multiple days of anodal tDCS. Neurobiol Learn Mem. 2019 Oct;164:107062. doi: 10.1016/j.nlm.2019.107062. Epub 2019 Aug 1.

  PMID: 31377178 BACKGROUND

• Lefebvre S, Laloux P, Peeters A, Desfontaines P, Jamart J, Vandermeeren Y. Dual-tDCS Enhances Online Motor Skill Learning and Long-Term Retention in Chronic Stroke Patients. Front Hum Neurosci. 2013 Jan 9;6:343. doi: 10.3389/fnhum.2012.00343. eCollection 2012.

  PMID: 23316151 BACKGROUND

• Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.

  PMID: 27679565 BACKGROUND

• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

  PMID: 28709880 BACKGROUND

• Cote P, Yu H, Shearer HM, Randhawa K, Wong JJ, Mior S, Ameis A, Carroll LJ, Nordin M, Varatharajan S, Sutton D, Southerst D, Jacobs C, Stupar M, Taylor-Vaisey A, Gross DP, Brison RJ, Paulden M, Ammendolia C, Cassidy JD, Loisel P, Marshall S, Bohay RN, Stapleton J, Lacerte M. Non-pharmacological management of persistent headaches associated with neck pain: A clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur J Pain. 2019 Jul;23(6):1051-1070. doi: 10.1002/ejp.1374. Epub 2019 Feb 28.

  PMID: 30707486 BACKGROUND

• Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.

  PMID: 34374330 BACKGROUND

• Houts CR, McGinley JS, Wirth RJ, Cady R, Lipton RB. Reliability and validity of the 6-item Headache Impact Test in chronic migraine from the PROMISE-2 study. Qual Life Res. 2021 Mar;30(3):931-943. doi: 10.1007/s11136-020-02668-2. Epub 2020 Oct 20.

  PMID: 33079313 BACKGROUND

• Eyres S, Carey A, Gilworth G, Neumann V, Tennant A. Construct validity and reliability of the Rivermead Post-Concussion Symptoms Questionnaire. Clin Rehabil. 2005 Dec;19(8):878-87. doi: 10.1191/0269215505cr905oa.

  PMID: 16323387 BACKGROUND

• Jabbari S, Salahzadeh Z, Sarbakhsh P, Rezaei M, Farhoudi M, Ghodrati M. Validity and Reliability of Persian Version of Henry Ford Hospital Headache Disability Inventory Questionnaire. Arch Iran Med. 2021 Oct 1;24(10):752-758. doi: 10.34172/aim.2021.111.

  PMID: 34816697 BACKGROUND

• Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23.

  PMID: 25912277 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

  PMID: 18388841 BACKGROUND

• Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.

  PMID: 29856244 BACKGROUND

• James G, Doe T. The craniocervical flexion test: intra-tester reliability in asymptomatic subjects. Physiother Res Int. 2010 Sep;15(3):144-9. doi: 10.1002/pri.456.

  PMID: 20146239 BACKGROUND

• Sebastian D, Chovvath R, Malladi R. Cervical extensor endurance test: a reliability study. J Bodyw Mov Ther. 2015 Apr;19(2):213-6. doi: 10.1016/j.jbmt.2014.04.014. Epub 2014 Apr 18.

  PMID: 25892374 BACKGROUND

• Versteegh T, Beaudet D, Greenbaum M, Hellyer L, Tritton A, Walton D. Evaluating the reliability of a novel neck-strength assessment protocol for healthy adults using self-generated resistance with a hand-held dynamometer. Physiother Can. 2015 Winter;67(1):58-64. doi: 10.3138/ptc.2013-66.

  PMID: 25931654 BACKGROUND

• Cleland BT, Galick M, Huckstep A, Lenhart L, Madhavan S. Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Brain Sci. 2020 Oct 9;10(10):719. doi: 10.3390/brainsci10100719.

  PMID: 33050340 BACKGROUND

• Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954.

  PMID: 9429990 BACKGROUND

• Stark RG, Reitmeir P, Leidl R, Konig HH. Validity, reliability, and responsiveness of the EQ-5D in inflammatory bowel disease in Germany. Inflamm Bowel Dis. 2010 Jan;16(1):42-51. doi: 10.1002/ibd.20989.

  PMID: 19475674 BACKGROUND

• Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.

  PMID: 16305273 BACKGROUND

• Jobin K, Campbell C, Schabrun SM, Schneider KJ, Smith A, Debert CT. The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocol. Contemp Clin Trials Commun. 2024 Sep 19;42:101370. doi: 10.1016/j.conctc.2024.101370. eCollection 2024 Dec.

  PMID: 39391228 DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Chantel T Debert, MD MSc FRCPC CSCN

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, researcher, and care providers will be blinded until after the analysis period, researchers will be assessing outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized placebo controlled clinical trial.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: October 17, 2022
• Study Start: November 3, 2022
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)