Concurrent tDCS for Chronic Pain in Adults With Cerebral Palsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGillette Children's Specialty Healthcare

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Trans Cranial Direct Current Stimulation

    Device

    Trans Cranial Direct Current Stimulation of target area.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Transcranial Direct-Current StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
17 Days
2

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.

Time frame
Through study duration, average of 24 weeks
3

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.

Time frame
From the first day of intervention to the last day of intervention, average 10 consecutive weekdays.
4

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.

Time frame
Through study duration, average of 24 weeks

Secondary outcomes

1

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.

Time frame
Baseline and up to 44 days after Day 1
2

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).

Time frame
Baseline and 21 days after Day 1
3

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).

Time frame
Baseline and 21 days after Day 1
4

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).

Time frame
Baseline and 21 days after Day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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