Concurrent tDCS for Chronic Pain in Adults With Cerebral Palsy

NCT07846436 | Not Yet Recruiting

• 1 other identifier: STUDY00028683
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 for chronic pain.

Conditions

Cerebral Palsy (CP); Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through study duration, average of 24 weeks

Secondary Outcomes (13)

• fMRI BOLD activation map volume in M1

  Baseline and up to 44 days after Day 1

• Brief Pain Inventory (BPI)

  Baseline and 21 days after Day 1

• Dallhousie Pain Interview

  Baseline and 21 days after Day 1

• Quality of Life Likert scale

  Baseline and 21 days after Day 1

• Fatigue Numeric Rating Scale

  Baseline and 21 days after Day 1

Study Arms (1)

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

Device: Trans Cranial Direct Current Stimulation

Interventions

Trans Cranial Direct Current Stimulation DEVICE

Trans Cranial Direct Current Stimulation of target area.

Transcranial Direct-Current Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead

MeSH Terms

Conditions

Cerebral Palsy; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mo Chen, PhD

  Gillette Children's Specialty Healthcare Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan St. Louis, BS

CONTACT

16512293862; jonsstlouis@gillettechildrens.com

Salma Noor, BS

CONTACT

651-229-3980; SalmaNoor@gillettechildrens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This is a prospective single-arm uncontrolled pilot study

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09