- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00349050
Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain.
The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods.
Participants with Neuropathic Pain:
After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC).
Healthy Volunteers:
In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.
Tipo de estudo
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29425
- Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
For Healthy Adults:
- Between age of 21 and 60
- No prescription medications in previous 3 months
- No seizure history
- No depression
- Not suicidal
- No anxiety
- No hospitalizations or surgeries in previous 6 months
- No history of chronic pain conditions
- No implanted metal devices (e.g., pacemakers, metal plates, wires)
- Not pregnant
- No alcohol abuse/dependence history in previous 6 months
- No illicit drug use in previous 6 months
- Capable of reading, writing, giving consent, following instructions
- No history of brain surgery or history of loss of consciousness >15 minutes
- No history of autoimmune or endocrine disorder
- No significant anxiety about entering MRI scanner
For Patients with neuropathic pain:
- Between age of 21 and 75
- No seizure history
- Not taking medications shown to increase seizure risk (6 months)
- Not suicidal
- No hospitalizations or surgeries in previous 3 months
- No implanted metal devices (e.g., pacemakers, metal plates, wires)
- Not pregnant
- No alcohol abuse/dependence history in previous 6 months
- No illicit drug use in previous 6 months
- Capable of reading, writing, giving consent, following instructions
- Chronic pain (>6 months), not significantly relieved by pharmacological treatment
- No significant anxiety about entering MRI scanner
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 1
laboratory pain assessment
|
Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments.
The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations.
As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
|
Comparador Ativo: 2
transcranial magnetic stimulation
|
There will be two, 20-minute, 3-day TMS treatment sessions.
Participants will be randomly assigned to one of two groups.
Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment.
Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment.
Regardless of the group, participants will receive both real and "sham" TMS.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
Prazo: measured during the study period
|
measured during the study period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeffrey J. Borckardt, Ph.D., Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- K23NS050485-01A2 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em laboratory pain assessment
-
University Hospital, LilleConcluídoSintoma Cognitivo | Avaliações, AutodiagnósticoFrança
-
Hopital FochRescindido
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Ainda não está recrutandoInfecções por HIV | Hepatite B
-
Shaare Zedek Medical CenterNanovibronixDesconhecido
-
Pfizer's Upjohn has merged with Mylan to form Viatris...ConcluídoNeuralgia | Dor neuropática | Dor no nervo
-
Duke UniversityConcluídoArtrite do Joelho | Artrite do quadrilEstados Unidos
-
Teesside UniversityConnect Health LtdConcluído
-
Ankara Yildirim Beyazıt UniversityRecrutamentoDor musculoesquelética | QuestionárioPeru
-
Shirley Ryan AbilityLabCoapt, LLCRecrutamentoAmputação de membro inferior abaixo do joelho (lesão) | Amputação de membro inferior acima do joelho (lesão) | Amputação | Dor do membro fantasma | Dor fantasma | Sensação Fantasma | Joelho para Amputação de Membro Inferior | Amputação de membro inferior no tornozelo (lesão) | Amputação de membro superior... e outras condiçõesEstados Unidos
-
University of FloridaAgency for Healthcare Research and Quality (AHRQ)Ainda não está recrutandoDor musculoesquelética | Dor crônica | Uso de opioides