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

NCT04248946 | Unknown DMC

• 1 other identifier: RG_18-269
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Conditions

Consciousness Disorder; Brain Injuries; Vegetative State; Minimally Conscious State

Outcome Measures

Primary Outcomes (4)

• 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)

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

• 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

  3 months after start of participation

• 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

  6 months after start of participation

• Completion

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

  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)

• Structural MRI

  day 1 and day 5 of tDCS each polarity

• Functional MRI in response to task instructions

  day 1 and day 5 of tDCS each polarity

• EEG power in the alpha band in response to task instructions

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

• EEG power in the beta band in response to task instructions

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

• EMG (electromyography) amplitude changes

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

Study Arms (2)

MRI stream

EXPERIMENTAL

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

Bedside stream

EXPERIMENTAL

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

Interventions

Transcranial direct current stimulation OTHER

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

Also known as: tDCS

Bedside stream; MRI stream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Birmingham: lead
• Wellington Hospital: collaborator

Study Sites (2)

Moseley Hall Hospital

Birmingham, West Midlands, B13 8JL, United Kingdom

Location

The Wellington Hospital

London, NW8 9LE, United Kingdom

Location

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries; Persistent Vegetative State

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Unconsciousness

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Davinia Fernandez Espejo, PhD FHEA

CONTACT

01214145534; d.fernandez-espejo@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 30, 2020
• Study Start: July 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)