Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04248946
Previous Study | Return to List | Next Study

Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study (RAINDROP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248946
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Wellington Hospital
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:
This study evaluates the feasibility of an experimental protocol that combines advanced multi-modal imaging of the brain with clinical and behavioural scales to characterise the neural, behavioural, and clinical effects of transcranial direct current stimulation (tDCS) for rehabilitation in PDOC

Condition or disease Intervention/treatment Phase
Consciousness Disorder Brain Injuries Vegetative State Minimally Conscious State Other: Transcranial direct current stimulation Not Applicable

Detailed Description:
Patients with prolonged disorders of consciousness (PDOC) have very limited therapeutic options, and they often show little to no progress over time. Here, the investigators will assess whether transcranial direct current stimulation can improve patients' responsiveness. The investigators will use a protocol designed to target specific brain networks that have been shown to play a key role in explaining the lack of voluntary responses in PDOC. The study will focus on characterising the mechanisms of action of tDCS and the bases for potential individual differences in responsiveness to the stimulation across participants. This feasibility study is the first step towards developing personalised tDCS interventions to restore external responsiveness in PDOC patients. Its results will inform the design of a future trial fully powered for characterising neural, behavioural, and clinical effects of tDCS in PDOC as well as the mechanisms underlying individual differences in responsiveness.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a double-blind randomised crossover feasibility study of tDCS in a small cohort of PDOC individuals. The study is divided into two streams to accommodate differences in the resources available across recruitment sites: 1. MRI stream, which will include MRI and electrophysiology assessments; this is available to patients receiving care at the Wellington Hospital in London only. 2. Bedside stream, which will include electrophysiology assessments only, available to patients in specialist units at NHS (National Health Service) and non-NHS sites
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In the MRI stream all participants will receive anodal, cathodal, and sham (placebo) tDCS sessions in a randomised order. In the Bedside stream participants will receive active tDCS (either anodal or cathodal) and sham sessions also in a randomised order. A researcher not involved in data collection or analyses will programme the stimulator to deliver the specific polarity needed in each session in a double-blind manner. Sham tDCS will be delivered according to published guidelines: this mimics the physical sensations of active stimulation but does not have a neuromodulatory effect
Primary Purpose: Basic Science
Official Title: Sham-controlled, Double-blind, Randomised Crossover Study of the Neural, Behavioural, and Clinical Effects of Transcranial Direct Current Stimulation in Patients With a Prolonged Disorder of Consciousness; Feasibility Study
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: MRI stream

In this stream all patients receive 2 experimental interventions (anodal tDCS and cathodal tDCS) and a sham intervention (sham tDCS). These are delivered in randomised order, ensuring a balanced distribution of participants across possible orders. They will receive 5 sessions per condition (on consecutive days), for a total of 15 sessions.

I. Anodal, cathodal, sham II. Anodal, sham, cathodal III. Cathodal, anodal, sham IV. Cathodal, sham, anodal V. Sham, anodal, cathodal VI. Sham, cathodal, anodal

Other: Transcranial direct current stimulation
tDCS alters neural excitability in a polarity-specific manner via a weak direct electric current delivered through electrodes placed on the scalp. There are 3 types of stimulation: anodal, cathodal, and sham. In anodal tDCS, the positive electrode is placed over the target brain area to increase neuronal excitability. In cathodal tDCS, the negative electrode is placed over the target brain area to decrease neuronal excitability. Sham tDCS emulates the physical sensations of active (anodal/cathodal) tDCS but current is only delivered for a short period of time and is not enough to cause any neuromodulations
Other Name: tDCS

Experimental: Bedside stream

In this stream all patients receive 1 experimental interventions (either anodal tDCS or cathodal tDCS) and 1 sham intervention (sham tDCS). These include only 1 session per condition and are delivered in randomised order, resulting in the following possible combinations:

I. Anodal, sham II. Cathodal, sham III. Sham, anodal IV. Sham, cathodal

Participants will be randomly assigned to the above groups ensuring a balanced distribution of participants across them.

Other: Transcranial direct current stimulation
tDCS alters neural excitability in a polarity-specific manner via a weak direct electric current delivered through electrodes placed on the scalp. There are 3 types of stimulation: anodal, cathodal, and sham. In anodal tDCS, the positive electrode is placed over the target brain area to increase neuronal excitability. In cathodal tDCS, the negative electrode is placed over the target brain area to decrease neuronal excitability. Sham tDCS emulates the physical sensations of active (anodal/cathodal) tDCS but current is only delivered for a short period of time and is not enough to cause any neuromodulations
Other Name: tDCS




Primary Outcome Measures :
  1. Retention at end of active phase [ Time Frame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream ]
    percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure)

  2. Retention at 3 months [ Time Frame: 3 months after start of participation ]
    percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure). This Outcome applies to the bedside stream only

  3. Retention at 6 months [ Time Frame: 6 months after start of participation ]
    percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure). This Outcome applies to the bedside stream only

  4. Completion [ Time Frame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream ]
    percentage of tDCS, MRI, and electrophysiology assessments completed per polarity


Secondary Outcome Measures :
  1. Structural MRI [ Time Frame: day 1 and day 5 of tDCS each polarity ]
    This will include assessments of the gross macrostructure, and microstructure of brain tissue grey matter, white matter, and cerebrospinal fluid

  2. Functional MRI in response to task instructions [ Time Frame: day 1 and day 5 of tDCS each polarity ]
    This will include assessments of the BOLD (blood oxygen level-dependent) response to characterise brain activity and connectivity during command following

  3. EEG power in the alpha band in response to task instructions [ Time Frame: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream ]
    Envelope of bandpass filtered EEG data between 8-12 Hertz

  4. EEG power in the beta band in response to task instructions [ Time Frame: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream ]
    Envelope of bandpass filtered EEG data between 13-30 Hertz

  5. EMG (electromyography) amplitude changes [ Time Frame: days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively ]
    Changes in the amplitude of the rectified EMG signal (high-pass filtered > 50Hz) in response to instructions to move

  6. Coma recovery scale -revised [ Time Frame: regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream ]
    clinical diagnostic scale for disorders of consciousness. Total score ranges from 0 to 23, where higher scores mean a higher level of functioning and awareness

  7. Glasgow Outcome Scale-extended [ Time Frame: at 3 and 6 months after start of participation ]
    Scale for functional outcome after brain injury. Total score ranges from 1 to 8, where higher values correspond to better outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or older
  • Receiving care at a recruitment site, with a consensus clinical diagnosis of PDOC from any aetiology (i.e. traumatic or non-traumatic injury).
  • Stable and with no need of mechanical support (i.e. respirator, etc.)

Exclusion Criteria:

  • Scalp skin sores or any skin damage at the electrode sites
  • Metallic implants in the face or skull
  • Craniectomy or cranioplasty
  • No evidence of auditory startle in clinical observations, or absent brainstem auditory evoked potentials in recent clinical history (if data available)
  • MRI incompatible: metal plates incompatible with MRI scanners, pacemaker, inability to lay flat for prolonged periods of time, aneurysm clips, neurostimulators, brain/subdural electrodes, etc. (MRI stream ONLY)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248946


Contacts
Layout table for location contacts
Contact: Davinia Fernandez Espejo, PhD FHEA 01214145534 d.fernandez-espejo@bham.ac.uk

Locations
Layout table for location information
United Kingdom
Moseley Hall Hospital Not yet recruiting
Birmingham, West Midlands, United Kingdom, B13 8JL
The Wellington Hospital Recruiting
London, United Kingdom, NW8 9LE
Contact: Antonio Incisa, PhD CPsychol CSci    +44 (0)20 7483 5595    Antonio.Incisa@HCAHealthcare.co.uk   
Sponsors and Collaborators
University of Birmingham
Wellington Hospital
Layout table for additonal information
Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04248946    
Other Study ID Numbers: RG_18-269
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Persistent Vegetative State
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Unconsciousness
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders