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Consciousness DisorderRAINDROPNCT04248946

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

A study testing Transcranial direct current stimulation in people with Consciousness Disorder and Brain Injuries, run by University of Birmingham at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcranial direct current stimulation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited Kingdom
Study dates
Jul 2021to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Davinia Fernandez Espejo, PhD FHEA contact

01214145534

d.fernandez-espejo@bham.ac.uk

United Kingdom2 sites

  • Moseley Hall Hospital

    Birmingham, West Midlands, B13 8JL

  • The Wellington Hospital

    London, NW8 9LE

    Antonio Incisa, PhD CPsychol CSci, +44 (0)20 7483 5595, Antonio.Incisa@HCAHealthcare.co.uk

Other trials in United Kingdom

About this study

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

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

Read the 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.

Medical subject headings
Consciousness Disorders, Brain Injuries, Persistent Vegetative State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulationOther

    Also called tDCS

    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

Study groups in NCT04248946
Study groupRoleWhat they receive
MRI streamExperimentalIn 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
Receives: Other: Transcranial direct current stimulation
Bedside streamExperimentalIn 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.
Receives: Other: Transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention at end of active phase

    percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure)

    Measured: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream

  2. Retention at 3 months

    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

    Measured: 3 months after start of participation

  3. Retention at 6 months

    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

    Measured: 6 months after start of participation

  4. Completion

    percentage of tDCS, MRI, and electrophysiology assessments completed per polarity

    Measured: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream

Secondary outcomes (7)

  1. Structural MRI

    This will include assessments of the gross macrostructure, and microstructure of brain tissue grey matter, white matter, and cerebrospinal fluid

    Measured: day 1 and day 5 of tDCS each polarity

  2. Functional MRI in response to task instructions

    This will include assessments of the BOLD (blood oxygen level-dependent) response to characterise brain activity and connectivity during command following

    Measured: day 1 and day 5 of tDCS each polarity

  3. EEG power in the alpha band in response to task instructions

    Envelope of bandpass filtered EEG data between 8-12 Hertz

    Measured: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream

  4. EEG power in the beta band in response to task instructions

    Envelope of bandpass filtered EEG data between 13-30 Hertz

    Measured: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream

  5. EMG (electromyography) amplitude changes

    Changes in the amplitude of the rectified EMG signal (high-pass filtered > 50Hz) in response to instructions to move

    Measured: days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively

  6. Coma recovery scale -revised

    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

    Measured: regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream

  7. Glasgow Outcome Scale-extended

    Scale for functional outcome after brain injury. Total score ranges from 1 to 8, where higher values correspond to better outcome

    Measured: at 3 and 6 months after start of participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study startJul 2021 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248946
Sponsor's protocol ID
RG_18-269
Acronym
RAINDROP
Status last verified
Apr 2021
First submitted
22 Jan 2020
Last updated
3 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation in people with Consciousness Disorder and Brain Injuries, run by University of Birmingham at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Davinia Fernandez Espejo, PhD FHEA (01214145534, d.fernandez-espejo@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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