Cerebral Palsy (CP)NeuropointNCT07846436
Concurrent tDCS for Chronic Pain in Adults With Cerebral Palsy
A study testing Trans Cranial Direct Current Stimulation in people with Cerebral Palsy (CP) and Chronic Pain, run by Gillette Children's Specialty Healthcare.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy (CP), Chronic Pain
- What is being tested?
- Trans Cranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Diagnosis of Cerebral Palsy
- Chronic pain associated with movement
- Own legal decision maker
- Current level of at least moderate pain (>=4 out of 10, as assessed by the average pain Eligibility text messages)
- Eligible for MRI without sedation
- Has a cellular device that can receive and respond to study text messages
- Has stable doses of prescription medications for at least 1 month prior to study participation and no anticipated change in medication plan during the participation.
Who cannot join
- Non-English speaking
- Non-verbal
- Implanted medical devices
- Any metal in the head
- Has had unexplained episodes of loss of consciousness
- Diagnosis of epilepsy or history of seizures
Show all 14Show fewer
- Diagnosis of bipolar disorder, schizophrenia, or autism spectrum disorder
- Damage of skin at sites of stimulation
- Currently suffering from severe or frequent headaches
- Has had a traumatic brain injury
- Any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia
- Pregnant
- Have previously used tDCS or TMS and had an adverse reaction
- Diagnosis of severe substance or alcohol use disorder within 3 months of enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Concurrent Transcranial Direct Current Stimulation and Motor Tasks for Chronic Pain in Adults With Cerebral Palsy: A Feasibility Pilot Study
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.
Read the detailed description
The objective of this study is to determine the feasibility of using concurrent tDCS (Starstim tES8, Neuroelectrics, Spain) and motor tasks (action observation or motor imagery, according to the M1 activation during task-fMRI) to treat chronic pain.
- Conditions
- Cerebral Palsy (CP), Chronic Pain
- Being tested
- Trans Cranial Direct Current Stimulation
- Keywords
- tdcs, Trans Cranial Direct Current Stimulation, Cerebral Palsy, Chronic Pain, CP
- Medical subject headings
- Cerebral Palsy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Cranial Direct Current StimulationDevice
Trans Cranial Direct Current Stimulation of target area.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct-Current Stimulation | Experimental | 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 Receives: Device: Trans Cranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 Days
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.
Measured: Through study duration, average of 24 weeks
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.
Measured: From the first day of intervention to the last day of intervention, average 10 consecutive weekdays.
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.
Measured: Through study duration, average of 24 weeks
Secondary outcomes (13)
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.
Measured: Baseline and up to 44 days after Day 1
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).
Measured: Baseline and 21 days after Day 1
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).
Measured: Baseline and 21 days after Day 1
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).
Measured: Baseline and 21 days after Day 1
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)
Measured: Baseline and 21 days after Day 1
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.
Measured: Baseline and 21 days after Day 1
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
Measured: Baseline and 21 days after Day 1
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.
Measured: Baseline and 21 days after Day 1
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.
Measured: Baseline and 21 days after Day 1
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.
Measured: Baseline and 21 days after Day 1
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).
Measured: Baseline and 21 days after Day 1
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.
Measured: Baseline and 21 days after Day 1
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
Measured: Through study duration, average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single-arm uncontrolled pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gillette Children's Specialty Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Chen, Gillette Children's Specialty Healthcare
- Investigators
- Mo Chen, PhD, Principal investigator, Gillette Children's Specialty Healthcare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846436
- Sponsor's protocol ID
- STUDY00028683
- Acronym
- Neuropoint
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Transcranial Direct Current Stimulation and Motor Tasks for Chronic Pain in Adults With Cerebral Palsy: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT07846436
- Acronym / sponsor ID
- Neuropoint / STUDY00028683
- Conditions
- Cerebral Palsy (CP), Chronic Pain
- Keywords
- tdcs, Trans Cranial Direct Current Stimulation, Cerebral Palsy, Chronic Pain, CP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gillette Children's Specialty HealthcareUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to determine the feasibility of using concurrent tDCS (Starstim tES8, Neuroelectrics, Spain) and motor tasks (action observation or motor imagery, according to the M1 activation during task-fMRI) to treat chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single-arm uncontrolled pilot study
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct-Current Stimulation | Experimental | Device: Trans Cranial Direct Current StimulationThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older
- Diagnosis of Cerebral Palsy
- Chronic pain associated with movement
- Own legal decision maker
- Current level of at least moderate pain (>=4 out of 10, as assessed by the average pain Eligibility text messages)
Key exclusion criteria (14 listed)
- Non-English speaking
- Non-verbal
- Implanted medical devices
- Any metal in the head
- Has had unexplained episodes of loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans Cranial Direct Current StimulationTrans Cranial Direct Current Stimulation of target area. | Device | Transcranial Direct-Current Stimulation |
Primary outcome
Feasibility of the protocol
Time frame: 17 Days
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.
Time frame: Through study duration, average of 24 weeks
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
Time frame: From the first day of intervention to the last day of intervention, average 10 consecutive weekdays.
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
Time frame: Through study duration, average of 24 weeks
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.
13 secondary outcomes
fMRI BOLD activation map volume in M1
Time frame: Baseline and up to 44 days after Day 1
Brief Pain Inventory (BPI)
Time frame: Baseline and 21 days after Day 1
Dallhousie Pain Interview
Time frame: Baseline and 21 days after Day 1
Quality of Life Likert scale
Time frame: Baseline and 21 days after Day 1
Fatigue Numeric Rating Scale
Time frame: Baseline and 21 days after Day 1
Days Affected by Pain
Time frame: Baseline and 21 days after Day 1
PROMIS Anxiety (Short form 8a)
Time frame: Baseline and 21 days after Day 1
PROMIS Depression (short form 8b)
Time frame: Baseline and 21 days after Day 1
painDETECT questionnaire
Time frame: Baseline and 21 days after Day 1
Pain Catastrophizing Scale
Time frame: Baseline and 21 days after Day 1
Patient Global Impression of Change
Time frame: Baseline and 21 days after Day 1
Qualitative tDCS Outcome Questions
Time frame: Baseline and 21 days after Day 1
Daily Average Pain Numeric Rating Scale
Time frame: Through study duration, average of 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mo Chen, PhD principal investigator
Gillette Children's Specialty Healthcare Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Trans Cranial Direct Current Stimulation in people with Cerebral Palsy (CP) and Chronic Pain, run by Gillette Children's Specialty Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan St. Louis, BS (16512293862, jonsstlouis@gillettechildrens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the protocol (time frame: 17 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.