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NCT Number: NCT04330547

Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.

The purpose of this study is to characterize and improve pain and nociception management in patients with disorders of consciousness (DOC). This project is divided into two phases, a first phase to evaluate pain level and a second phase which consist of a clinical trial to evalute pain medication efficacy.

The main aim is to evaluate the use of the Nociception Coma Scale-Revised (NCS-R) and its cut-off score (i.e., 5) as an assessment and management tool to define guidelines for managing pain in patients with DOC. In this double-blind, placebo-controlled clinical study, we will evaluate the use of analgesic treatments in reducing pain in subacute/chronic patients. The project will also allow us to validate the NCS-R cut-off score defined previously.

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Key information

Conditions

Disorders of Consciousness Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Mental Disorders Minimally Conscious State Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Persistent Vegetative State Post-comatose Non-communicative Patients Severe Brain Injury Signs and Symptoms Trauma, Nervous System Unconsciousness Vegetative State Wounds and Injuries

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

About this study

The study will be performed within one week (i.e, 7 days) and consists of two phases:

  • Phase 1 "Patients selection (D0)": Patients will be assessed by the NCS-R during experimental stimulation (rest, tactile, noxious) and mobilizations (physiotherapy). Patients with potential pain will be included in the phase 2.
  • Phase 2 "Analgesic administration (D1 and D2)": double-blind placebo-controlled randomized clinical trial on potential responders identified in phase 1. A medical doctor of our team will suggest to the physician in charge to prescribe the dedicated medication. One placebo and one real treatment will be administered on day 1 and 2 by the nurses at least half-hour before the physiotherapy. Randomization between day 1 and 2 will be applied at that time.

For each day of phase 1 and 2, several assessments will be performed: NCS-R, CRS-R and spasticity assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have had an acquired brain injury with a loss of consciousness > 28 days (patients) or have no history of previous brain injury (healthy controls)
  • Legally authorized surrogate available to provide informed consent.
  • Diagnosis of vegetative/unresponsive (VS/UWS) or minimally conscious state (MCS) or emergence of the minimally conscious state without communication (eMCS; as defined by the CRS-R, see above).
  • Medically stable (i.e., no systemic illness or disease).
  • Patients with NCS-R score during mobilization above or equal to the previously determined cut-off score or NCS-R scores during mobilization equivalent to NCS-R score obtain during nociceptive stimulation will be included in the second phase of the study (i.e. D1 and D2).

Exclusion criteria

  • History of developmental, neurologic, or major psychiatric disorder resulting in functional disability.
  • Contraindication or unwillingness to discontinuing sedating and centrally-active drugs (benzodiazepine, long-acting sedating drugs) within 48 hours of assessment.
  • Upper limb contusions, fractures or flaccid paralysis.
  • Uncontrolled epilepsy and already on level 1 drugs

Treatment and study plan

Analgesic administration

Drug
  • Level 1 : Paracétamol 1g/Acetaminophène 1g, Ibuprofène 600mg, Diclofénac 50mg.
  • Level 2: Tramadol 50mg.
  • Level 3: Oxycodone 5mg, Morphine sulfate 10mg.
  • Increase of a prior level 3 medication :
  • 1/6 of the total dose of daily level 3 medication (e.g. the patient receives 30mg of oxycodone a day. He will be administered a single dose of 5 mg for the study), defined as a breakthrough dose in the management of chronic pain. To standardize the treatment, the dose of the prior level 3 medication will be converted to oxycodone. Several online tools exist to do the conversion between opioids (e.g. mobile app Orthodose ®).
  • If the oral intake or the gastrostomy use is not possible, the breakthrough dose will be administered by subcutaneous route. The dose will also be 1/6 of the daily dose and will be converted to injectable morphine. Conversion to injectable morphine will be performed with any equivalence tool (such as the mobile app Orthodose ®)

Placebo Administration

Drug

Folavit (folic acid, 0.4 mg)

Primary outcomes

  1. Nociception Coma Scale-Revised (NCS-R)

    Time frame: through study completion, an average of 2 years

    The NCS-R (Chatelle et al., 2012) is used to assess the perception of acute pain in patients with disorders of consciousness. It is composed of 3 subscales (motor, verbal and facial expressions) respectively scoring from 0 (no response) to 3 (highest response level). Here the NCS-R is administered in 4 different conditions: at rest, during tactile stimulation, during experimental nociceptive stimulation (pressure on the bed of the left and right nail) and during mobilization (physiotherapy).

  2. Coma Recovery Scale-Revised (CRS-R)

    Time frame: through study completion, an average of 2 years

    The CRS-R (Giacino et al., 2004) is the gold standard for the behavioural assessment of the level of consciousness and is widely used in patients with chronic disorders of consciousness. The CRS-R is composed of six subscales that assess the following domains: visual, motor, auditory and oro-motor/verbal functions, as well as communication, and arousal. The score ranges from 0 to 23, in which the lowest score indicates coma and the highest score indicates the emergence from the minimally conscious state. The diagnosis is made according to the presence\\absence of particular behavioural responses.

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: through study completion, an average of 2 years

    The MAS (Bohannon et al., 1987) is used to assess spasticity (reflex contraction in response to passive stretching). This is a scoring scale from 0 (no increase in muscle tone) to 4 (very strong increase in tone, stiffness), which will depend on the speed of execution of the movement (the faster the limb will be mobilized the more spastic it will be) and which must be performed at least 3 times for each joint.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness: a Double-blind Placebo-controlled Clinical Study.

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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