ClinicalTrials.gov
ClinicalTrials.gov Menu

tDCS Associated With Peripheral Electrical Stimulation for Pain Control in Individuals With Sickle Cell Disease (tDCS/PES_SCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02813629
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : September 24, 2018
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by (Responsible Party):
Faculdade Adventista da Bahia

Brief Summary:
So far, no study investigated the safety and efficacy analgesic of transcranial direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) in individuals with SCD who suffer from chronic pain. Several studies have reported a decrease in O²Hb concentration in the regions below the electrodes and in other cortical areas during anodic or cathodic tDCS, which implies a risk factor for vasoocclusive events in individuals with SDC due to polymerization of hemoglobin when exposed to these low O²Hb concentrations. For this reasion, the aim main of this study is to assess the effect of a single session of transcranial direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) on safety and efficacy analgesic in individuals with sickle cell disease (SCD). Others aims sencondaries are evaluate the effect of a single session of transcranial direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) on biomarkers neurophysiological and inflammatory.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Chronic Pain Device: tDCS plus PES Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation Associated With Peripheral Electrical Stimulation for Pain Control in Individuals With Sickle Cell Disease
Study Start Date : March 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SS-tDCS (active) plus PES (active)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Active Comparator: SS-tDCS (active) plus PES (simulated)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Active Comparator: SS-tDCS (simulated) plus PES (active)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Sham Comparator: SS-tDCS (simulated) plus PES (simulated)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Active Comparator: SC-tDCS (active) plus PES (active)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Active Comparator: SC-tDCS (active) plus PES (simulated)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Active Comparator: SC-tDCS (simulated) plus PES (active)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)

Sham Comparator: SC-tDCS (simulated) plus PES (simulated)
tDCS plus PES (n=15).
Device: tDCS plus PES

transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.

PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.

Other Names:
  • transcranial direct current stimulation (tDCS)
  • peripheral electrical stimulation (PES)




Primary Outcome Measures :
  1. Change in pain intensity [ Time Frame: One day ]

    Pain assessment at before and after each intervention:

    Actual pain intensity will be assessed using a 0-10 visual analogue scale (VAS), where 0 is no pain and 10 the worst imaginable pain. Visual analogue scale allows to evaluate the intensity pain of a quantitative way, the subjects will fill a VAS before and after treatment.



Secondary Outcome Measures :
  1. Analysis of brain waves delta, theta, alpha and beta [ Time Frame: One day ]
    - Analysis of brain waves: Individuals will be submitted to electroencephalogram following the international classification 10/20 for placement of the electrodes. The researchers will use 30 electrodes referenced by Cz point, ground electrode in Fz point of each individual and the impedance kept below 5 K ohms in all electrodes with a sampling frequency of 600 Hz. All records will be made with closed eyes lasting 4 minutes.

  2. Dosages of TNF-alpha and BDNF in patients with SCD [ Time Frame: One day ]

    - Assessment Dosages of tumor necrosis factor alpha (TNF-alpha) will be properly processed and the serum stored at -20ºC. Detection and quantification of serum levels will be performed by Enzyme-linked Immunosorbent Assay (ELISA) according to the manufacturer's instructions, being considered as normal reference values ≤15 pg / ml for IL-8 and p ≤7,8 / mL for TNF-alpha.

    Dosages of neurotrophin brain-derived neurotrophic factor (BDNF) will be properly processed and the serum stored at -20ºC. The detection and quantification of serum levels will be performed by Enzyme-linked Immunosorbent Assay (ELISA) according to the manufacturer's instructions. The detection limits for the BDNF will be 15 pg/ml.


  3. Motor cortical reorganization [ Time Frame: One day ]
    This outcome will be evaluated with a transcranial magnetic stimulator of single pulse . The procedure consists of ten pulses around the skull vertice with 200μV amplitude.

  4. Impact of pain in functionality [ Time Frame: One day ]
    Assessment of impact of pain in functionality before treatment with a pain disability index (PDI) will be used only in baseline PDI is a 7 questions questionnarie that will be used assess limitations imposed by the presence of pain in daily life activities

  5. Hospital anxiety and depression scale (HADS) [ Time Frame: One day ]
    This scale allows to evaluate objectively both aspects of anxiety and depression. Consists of 2 subscales, each one with 7 items. It will be used to identify the level of anxiety and depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being diagnosed with sickle cell disease hemoglobin electrophoresis.
  • Be aged 18 years old to 50 years old.
  • Having signed the consent form and clarified.
  • Having chronic pain with at least 3 months duration.
  • Being diagnosed with femoral head osteonecrosis
  • Have more than one type of chronic pain.

Exclusion Criteria:

  • Have cochlear implants, pacemakers or metallic implant in the skull / brain;
  • Have metallic implant application site of peripheral stimulation;
  • History of head trauma;
  • Pregnancy;
  • seizures or epilepsy History;
  • Being in drug use that modify neuronal activation threshold (eg antidepressants and anticonvulsants);
  • Having diagnosis of fibromyalgia, or any impairment to be confused with the symptoms of SCD;
  • Have pain confirmed neuropathic type.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813629


Contacts
Contact: Abrahão F Baptista, Prof. 55 11 98830-3941 a.baptista@ufabc.edu.br
Contact: Tiago S. Lopes, Sr 55 75 99963-6349 tslopes.physio@gmail.com

Locations
Brazil
Functional Electrical Stimulation Laboratory Recruiting
Salvador, Bahia, Brazil, 40110-902
Contact: Abrahão F Baptista, Prof.    55 71 3283-8906    a.baptista@ufabc.edu.br   
Sponsors and Collaborators
Faculdade Adventista da Bahia
Federal University of Bahia
Investigators
Principal Investigator: Abrahão F Baptista, Prof. Federal University of Bahia
Study Director: Wellington S Silva, Prof. Faculdade Adventista da Bahia

Publications:
Lima MC, Riberto M, Batistella LR, Boggio PS, Fregni F. Estimulação cerebral para o tratamento de dor neuropática. Psicol. teor. prát. 2007; 9(2):142-149
Brunoni AR, Pinheiro FS, Boggio PS. Estimulação transcraniana por corrente contínua: in Fregni F, Boggio PS, Brunoni AR. Neuromodulação Terapêutica: Princípios e Avanços da Estimulação cerebral não invasiva em Neurologia, reabilitação, Psiquiatria e Neuropsicologia. São Paulo: Sarvier. 2012: 65-75.

Responsible Party: Faculdade Adventista da Bahia
ClinicalTrials.gov Identifier: NCT02813629     History of Changes
Other Study ID Numbers: 31237514.1.0000.0042
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Faculdade Adventista da Bahia:
transcranial Direct Current Stimulation
Peripheral Electrical Stimulation
Sickle Cell Disease
Transcutaneous Electrical Nerve Stimulation
quantitative Electroencephalography

Additional relevant MeSH terms:
Anemia, Sickle Cell
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn