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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04248946
Other study ID # RG_18-269
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2021
Est. completion date August 2022

Study information

Verified date April 2021
Source University of Birmingham
Contact Davinia Fernandez Espejo, PhD FHEA
Phone 01214145534
Email d.fernandez-espejo@bham.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
United Kingdom Moseley Hall Hospital Birmingham West Midlands
United Kingdom The Wellington Hospital London

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham Wellington Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Structural MRI This will include assessments of the gross macrostructure, and microstructure of brain tissue grey matter, white matter, and cerebrospinal fluid day 1 and day 5 of tDCS each polarity
Secondary 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 day 1 and day 5 of tDCS each polarity
Secondary EEG power in the alpha band in response to task instructions Envelope of bandpass filtered EEG data between 8-12 Hertz days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream
Secondary EEG power in the beta band in response to task instructions Envelope of bandpass filtered EEG data between 13-30 Hertz days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream
Secondary EMG (electromyography) amplitude changes Changes in the amplitude of the rectified EMG signal (high-pass filtered > 50Hz) in response to instructions to move days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively
Secondary 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 regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream
Secondary 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 at 3 and 6 months after start of participation
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