Targeting pain mechanisms from the 'top-down' and the 'bottom-up' in chronic tension-type headache

An investigation of non-invasive brain and spinal cord stimulation versus brain stimulation (with sham spinal cord stimulation), and spinal cord stimulation (with sham brain stimulation) in people with chronic tension-type headache to evaluate feasibility, safety and effect on chronic tension type headache intensity, frequency and duration.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000091606

Enrollment

Registered

2014-01-23

Start date

2014-06-09

Completion date

2014-10-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Tension-type headache (TTH) is the most common and costly primary headache disorder. Up to 2-5% of individuals with TTH experience severe, persistent and disabling headaches (chronic tension-type headache; CTTH). CTTH is a major health problem and currently, there are few effective therapies available for CTTH, which only target generic symptoms. Recent work has revealed a role for biological mechanisms in affecting pain in CTTH. Therefore, novel therapies that aim to target the biological mechanisms are needed to reduce the social and economic burden on sufferers and the wider community. Here we aim to conduct a 'proof of concept' study to investigate the use of an innovative 'top-down' and 'bottom-up' approach to therapy through the combined application of transcranial (tDCS) and transspinal direct stimulation (tsDCS). This study will provide the initial test of the feasibility, safety and potential benefit on pain outcomes. We anticipate that the combination of tDCS and tsDCS will have an affect on improving CCTH intensity, frequency and duration by targeting the biological mechanisms that contribute to pain.

Interventions

Participants will receive 30 minutes of combined active transcranial direct current stimulation (tDCS) and active transspinal direct current stimulation (tsDCS) for five consecutive daily sessions. Transcranial direct current stimulation (tDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be placed over the primary motor cortex and the reference electrode (cathode) over the contralateral supraorbital region. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period. Transspinal direct current stimulation (tsDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be positioned over the thoracic spinal cord at the tenth thoracic vertebra and the reference electrode (cathode) above the right shoulder. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants with a diagnosis of chronic tension-type headache (CCTH) according to the international Classification of Headache Disorders, 2nd edition (ICHD-II) criteria will be recruited. Additional inclusion criteria will comprise: i) diagnosis of CTTH for greater than 12 months prior to commencing the trial, ii) experience painful episodes on 15 or more days per month, iii) experience painful episodes that last more than 4 hours when untreated, and iv) experienced symptom onset before age 50 years.

Exclusion criteria

Individuals under 18 years or who present with neurological or psychiatric conditions or use of prophylactic migraine drugs will be excluded.

Outcome results