About this trial
The purpose of this study is to find out whether combining transcranial direct current stimulation (tDCS) using the Starstim tES8 device with motor-based activities, such as action observation or motor imagery (chosen based on task-fMRI results showing activation in the primary motor cortex), is a feasible treatment for chronic pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Diagnosis of Cerebral Palsy
Chronic pain associated with movement
Own legal decision maker
Disqualifiers
Non-English speaking
Non-verbal
Implanted medical devices
Any metal in the head
Trial design
Single group
Treatments tested in this trial
Trans Cranial Direct Current Stimulation
DeviceTrans Cranial Direct Current Stimulation of target area.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of the protocol
Feasibility of study procedures will be determined based on ≥60% retention through the follow-up participant surveys, and (2) ≥60% adherence to scheduled intervention sessions.
Acceptability of the protocol.
Aim will be evaluated using the following methods: Acceptability will be measured using the Theoretical Framework of Acceptability (TFA) which is an 8-item measure used to assess intervention acceptability. Each item measures a different component of acceptability ranging from a 1-5 Likert scale.
Intervention tolerability
Tolerability will be assessed by monitoring side effects/adverse events, through structured assessments and clinical interactions. At all intervention session visits, the tDCS operator will conduct a general inquiry regarding how the participant is feeling, go through a structured assessment of potential side effects/symptoms, and visually inspect the skin at the site of stimulation for redness or irritation before and after each tDCS session. Adverse events will be coded on a standardized Adverse Events tracking form. The PI or delegated investigator will assess all adverse effects for their severity, their unexpectedness, their relation to study procedures, and whether they represent increased risk to other participants or the greater community.
Participant burden associated with the intervention
Participant burden will be quantified by asking participants to report their travel time, recording the duration of participant visits, and providing an open text box for participant feedback on study burden. These will be combined to determine the feasibility of concurrent tDCS and motor tasks for the treatment of chronic pain in adults with CP.
Secondary outcomes
fMRI BOLD activation map volume in M1
Task functional magnetic resonance imaging (fMRI) activation intensity during the two motor tasks. Intensity is represented as the Blood oxygen level dependent (BOLD) map volume (integration of z-score within activated regions in M1. This will be assesed through M1 activation during the task fMRI will be assessed. If M1 can be activated according to the first-level neuroimaging analysis, it is considered as feasible to have tDCS concurrent with the corresponding motor taskfor adult CP with chronic pain. These measures will be combined to gain preliminary understanding whether the motor tasks, motor imagery and action observation, are suitable to be paired concurrently with tDCS over M1 for chronic pain treatment in adults with CP.
Brief Pain Inventory (BPI)
This survey utilizes Pain Interference Items that assess the degree to which pain interferes with activities of daily living (e.g., sleep, relationships, and mobility). Items are scored on a 10-point scale (0 = does not interfere, 10 = completely interferes).
Dallhousie Pain Interview
The Dalhousie Pain Interview (DPI) uses a 10-item survey to quantify pain intensity (scored 0-10), duration (minutes/seconds in pain), pain frequency (number of pain episodes), cause, description, and methods of treatment for pain reported in the last week. DPI also asks about chronic pain (pain that has lasted longer than 3 months).
Quality of Life Likert scale
Participants will be asked to rate their overall quality of life in the past week (5-point Likert scale ranging from Very Poor to Very Good).
Locations
Sponsors and contacts
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