Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation

NCT04650048 | Unknown

• 1 other identifier: N-20180085.p2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (HD-tDCS) on an experimental prolonged pain model in healthy subjects.

Conditions

Pain, Muscle; Healthy

Outcome Measures

Primary Outcomes (2)

• Change in pressure pain threshold.

  A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold. The pressure is increased gradually at a rate of 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle.

  Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.

• Change in pressure pain tolerance.

  A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold at baseline. The pressure is increased gradually at a rate of 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle. The participant is asked to rate the pain on a numerical rating scale (NRS) from 0-10. 0 representing no pain at all, and 10 representing the worst pain imaginable.

  Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.

Secondary Outcomes (5)

• Change in tactile detection threshold

  Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.

• Change in mechanical pain threshold

  Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.

• Change in conditioned pain modulation (CPM)

  Three assessments over three days: Baseline is assessed before the stimulation at day one, and then again after the stimulation on the two subsequent days.

• Change in temporal summation of pain (TSP).

  Three assessments over three days: Baseline is assessed before the stimulation at day one, and then again after the stimulation on the two subsequent days.

• Change in electroencephalography response (EEG).

  Three assessments over three days: The EEG will be recorded as a part of the HD-tDCS intervention.

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Both groups will receive an injection with 5 μg (0.5 ml) Nerve Growth Factor (NGF) in the first dorsal interosseous muscle (FDI muscle) prior to the HD-tDCS intervention. This injection a pain model, that is intended to induce muscle soreness and hyperalgesia.

Device: Active HD-tDCS

Sham tDCS

PLACEBO COMPARATOR

Both groups will receive an injection with 5 μg (0.5 ml) Nerve Growth Factor (NGF) in the first dorsal interosseous muscle (FDI muscle) prior to the HD-tDCS intervention. This injection a pain model, that is intended to induce muscle soreness and hyperalgesia.

Device: Sham HD-tDCS

Interventions

Active HD-tDCS DEVICE

Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes.

Active tDCS

Sham HD-tDCS DEVICE

Using the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds. This sham-configuration is intended to mimic the sensory experience of active HD-tDCS.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women.
• Able to speak, read and understand English or Danish.

You may not qualify if:

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Current use of opioids, antipsychotics, benzodiazepines
• Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
• Current or prior chronic pain conditions
• Lack of ability to cooperate

Sponsors & Collaborators

• Aalborg University: lead
• Danish National Research Foundation: collaborator

Study Sites (1)

Center for Neuroplasticity and Pain

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Graven-Nielsen, Prof.

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Kold, MSc

CONTACT

+4522850345; sks@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants are pseudo-randomly allocated to either the intervention or the control group so as the two groups are equally weighted on gender. Using the build in double-blind software of the HD-tDCS device, the participant as well as investigator is blinded to the protocol that is administered.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. fellow

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: December 2, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: April 29, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-12

Locations

DK (1)