Concurrent tDCS for Chronic Pain in Adults With Cerebral Palsy

Browse trials for

• Cerebral Palsy 1,850
• Chronic Pain 2,924

Keywords

• tdcs
• Trans Cranial Direct Current Stimulation
• Cerebral Palsy
• Chronic Pain
• CP

Study arms

• Experimental
  Transcranial Direct-Current Stimulation

  This is the arm of intervention with participant receiving MRI Scan with Action Observation or Motor Imagery, Transcranial Magnetic Stimulation Motor Cortex excitability assessment, and Transcranial Direct-current Stimulation

  Device: Trans Cranial Direct Current Stimulation

Interventions

• DeviceTrans Cranial Direct Current Stimulation

  Trans Cranial Direct Current Stimulation of target area.

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

5. Fatigue Numeric Rating Scale

   Participants will be asked to rate overall how tired they have been in the past week (0-10 ranging from Not tired to Total exhausation)

   Time frame: Baseline and 21 days after Day 1

6. Days Affected by Pain

   Participants will be asked to report the number of days in the past week pain made it hard for them to do their usual activities. This item is adapted from the Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire (BRFSS) Module 3: Health Days (Symptoms) portion.

   Time frame: Baseline and 21 days after Day 1

7. PROMIS Anxiety (Short form 8a)

   an 8-item survey used to assess anxiety-related feelings including those of fear, hyperarousal, and somatic symptoms. Raw scores range from 8-40, with higher scores indicating more anxiety-related feelings

   Time frame: Baseline and 21 days after Day 1

8. PROMIS Depression (short form 8b)

   An 8-item survey used to assess depression-related feelings including negative mood, self-views, and social cognition and engagement. Raw scores range from 8-40, with higher scores indicating more depression-related feelings.

   Time frame: Baseline and 21 days after Day 1

9. painDETECT questionnaire

   A questionnaire used to screen for components of neuropathic pain and distinguish between neuropathic and nociceptive pain types. Scores range from 0-38 with scores of 0-12 indicating nociceptive pain, 13-18 indicating unclear pain type, and 19-38 indicating neuropathic pain.

   Time frame: Baseline and 21 days after Day 1

10. Pain Catastrophizing Scale

    A 13-item survey used to assess feeling and emotions, including catastrophizing thinking, one may experience when they are in pain. Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.

    Time frame: Baseline and 21 days after Day 1

11. Patient Global Impression of Change

    The Patient Global Impression of Change will be used to assess from a participant's perspective the significance of change in their condition since beginning intervention. Utilizing 2 questions to assess this, one that focuses on their chronic pain improvement (7-point Likert scale ranging from Very much worse to Very much better) and one focusing on changes in symptoms, emotions, activities, and quality of life (7-point Likert scale ranging from No change to A great deal better).

    Time frame: Baseline and 21 days after Day 1

12. Qualitative tDCS Outcome Questions

    Qualitative tDCS Outcome Questions are 3 open-ended questions regarding the helpfulness of tDCS for their pain, improvements in daily life as a result of tDCS, and whether they would consider tDCS as a treatment for their chronic pain if it was clinically available.

    Time frame: Baseline and 21 days after Day 1

13. Daily Average Pain Numeric Rating Scale

    The text message surveys will be a Numeric Rating Scale (NRS) ranging from 0-10, and will be used to quantify participants' daily average and current pain, sleep quality, and mood

    Time frame: Through study duration, average of 24 weeks

Individual participant data

Plan to share: Undecided