Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheffield Teaching Hospitals NHS Foundation Trust
About this trial
Aphasia is an acquired language disorder. Stroke is the most common cause of aphasia, which affects 30% of stroke survivors. Speech and Language Therapy (SLT) can help people with aphasia but it may not be provided at the required intensity. Access to therapy is often limited after the first few months following stroke. People with aphasia can improve with therapy many years after stroke but these benefits have not been found to translate to day to day conversation.
Transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive technique which involves stimulating a branch of the vagus nerve through the skin of the ear, using a small earpiece. This technique is safe and has been approved for use in headache. There is promising evidence that tVNS can improve motor rehabilitation in chronic stroke. This technique may be helpful in aiding language recovery in individuals with chronic aphasia.
The current pilot study will primarily assess the feasibility, safety and tolerability of self-directed tVNS paired with computer-based SLT, in individuals with chronic stroke-related aphasia. Secondly, the study aims to explore the effect of the intervention on word-finding ability and to explore potential mechanisms of action. Participants will be randomly allocated to an active or sham tVNS group. Participants will be asked to use the stimulation device at home for 6 weeks, whilst completing computer-based SLT. To date, there are no published studies exploring the use of tVNS in aphasia. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Supratentorial stroke at least 6 months prior to recruitment
Aphasia (with word finding difficulties)
Ability to engage in the programme (support can be provided for cognitive or receptive difficulties)
Sufficient vision to engage in the computer-based SLT programme
Disqualifiers
Implanted devices (e.g. pacemaker) or implanted stimulation devices
Currently receiving a programme of Speech and Language Therapy (SLT)
Damage to the vagus nerve
Symptomatic bradycardia/ 2nd or 3rd heart block
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Vagus Nerve Stimulation
DeviceTranscutaneous auricular vagus nerve stimulation using the Nurosym (Parasym Ltd) device. Stimulation parameters: Pulse width: 250µs; Frequency: 25Hz; Intensity: Below pain threshold. The active stimulation will be delivered to the left ear. Participants will complete the intervention at home once they have received sufficient training on how to use the stimulation device.
Sham Transcutaneous Vagus Nerve Stimulation
DeviceStimulation will be delivered at the same parameters however, sham stimulation will be delivered to the left ear. This sham method has been used as a sham in other studies as it is not thought to activate the vagus nerve.
Computer Based Speech and Language Therapy (Step by Step)
BehavioralComputer-based Speech and Language Therapy will be completed whilst wearing the stimulation device in all groups. The Step by Step programme uses an errorless learning approach to practice naming. All participants will practice a set of 30 meaningful words during the intervention. Participants will complete the SLT programme at home on an ipad, whilst using the stimulation device.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Transcutaneous Vagus Nerve StimulationExperimental treatment 2 interventions
Group B: Sham Transcutaneous Vagus Nerve StimulationSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Safety: The number of adverse events reported that are associated with tVNS
The safety of using tVNS in the aphasia population will be measured through the recording of adverse events. The number of Serious Adverse Events (SAE's) and Unexpected Adverse Events (UAE's) during the intervention will be reported.
Time frame
6 weeks2
Tolerability: The number and intensity of symptoms reported
The reporting of symptoms associated with tVNS will be recorded and the severity of each symptom on a 1-5 scale (1= mild; 5 = severe).
Time frame
6 weeks3
Percentage of participants completing the study intervention and outcome measures
\>80% of recruited participants completing the intervention and primary outcome measures at 6 weeks
Time frame
24 monthsSecondary outcomes
1
Picture Naming (personally relevant)
The number of pictures that are accurately named at each time point, out of a maximum of 30. Pictures will be personally relevant and selected by the participant prior to the start of the intervention. These pictures will be trained during the computer-based SLT intervention. Naming will be assessed at baseline, end of treatment (6 weeks) and at follow-up (12 weeks) using the same picture set.
Time frame
Week 0; Week 6; Week 122
The Comprehensive Aphasia Test (CAT): Naming Objects
The number of pictures that are accurately named at each time point, out of a maximum of 48. A standardized set of 24 pictures will be used from The Comprehensive Aphasia Test (CAT) Naming Objects subtest. This will assess the ability to name untrained words. This task will be completed at baseline, end of treatment (6 weeks) and at follow-up (12 weeks).
Time frame
Week 0; Week 6; Week 123
Conversation: The number of trained words used in conversation
A 10 minute scripted conversation will be conducted for each participant, surrounding topics of personal relevance, to prompt the use of trained words in a conversational context. The number of times a word is used will be recorded
Time frame
Week 0; Week 6; Week 124
Brain Derived Neurotrophic Factor (BDNF) (ng/ml)
Blood samples will be taken at baseline and end of treatment (6 weeks) to measure BDNF levels in serum
Time frame
Week 0; Week 6Sponsors and contacts
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Source ClinicalTrials.gov