Pain Clinical Trial
Official title:
Transcranial Direct Current Stimulation Effect on Pain Threshold and Working Memory in Healthy Adolescents, Young Adults and Elderly: a Randomized , Cross-over, Single Blind Trial
Verified date | March 2020 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation method which has great potential as an aid in the therapeutic management of neuropsychiatric disorders and chronic pain syndromes. However, despite promising results, the response to stimulation presents great variability among subjects. Age is a factor that is known to influence the tDCS effect forging the inconsistency of clinical effect.The purpose of this study is to evaluate the effect of tDCS on pain perception and working memory in healthy women from 3 different age groups: adolescents, young adults and elderly. This is a randomized, single-blinded, cross-over study of 2 different active interventions and sham.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age between 15 to 16 years for the adolescent group - Age between 30 to 40 years for the young adult group - Age between 60 to 70 years for the elderly group - From completed elementary school to incomplete superior education - right handed Exclusion Criteria: - Pregnancy - Current smoker or previous smoker within 10 years - Current Substance Use Disorder - Neurological condition (e.g., traumatic brain injury, stroke, brain tumor, epilepsy, brain surgery, brain implant) - Any diagnosed Psychiatric condition (e.g., Attention deficit/hyperactivity deficit (ADHD), bipolar disorder, major depressive disorder, schizophrenia, generalized anxiety disorder) - Use of any antidepressive or psychoactive, psychostimulant medication - Any chronic pain condition |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas e Porto Alegre (HCPA) | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
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Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23 — View Citation
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Palm U, Segmiller FM, Epple AN, Freisleder FJ, Koutsouleris N, Schulte-Körne G, Padberg F. Transcranial direct current stimulation in children and adolescents: a comprehensive review. J Neural Transm (Vienna). 2016 Oct;123(10):1219-34. doi: 10.1007/s00702-016-1572-z. Epub 2016 May 12. Review. — View Citation
Scharinger C, Soutschek A, Schubert T, Gerjets P. When flanker meets the n-back: What EEG and pupil dilation data reveal about the interplay between the two central-executive working memory functions inhibition and updating. Psychophysiology. 2015 Oct;52(10):1293-304. doi: 10.1111/psyp.12500. Epub 2015 Aug 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heat pain Threshold | Using the Quantitative sensory testing, this measure consists of the average temperature of 3 stimulus with increasing magnitude of heat where the participant presses a button to indicate when he/she first perceives pain. | percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session | |
Primary | Working memory performance | Working memory performance will be evaluated by a computerized n-back test associated with flankers at baseline and after each session of active tDCS (DLPFC or M1) or sham. The measure of performance is the D' discrimination index (calculated based on hit rate and false alarm rate). | up to 60 minutes after tDCS onset | |
Secondary | Inhibitory control performance | A computerized stop-signal task associated with flankers will evaluate inhibitory control. Performance index are calculated with the D' discrimination index (based on hits and false alarms for go and stop trials). The task will be performed at baseline and after the stimulation on each cross-over session. | up to 60 minutes after tDCS onset | |
Secondary | Area under the curve of the ERP during inhibitory control task | Area under the curve of the signal of event-related potential (ERP) evoked during the stop signal task with flankers (inhibitory control performance). The signal will be assessed using an 8 channel EEG device at baseline and after each cross-over session. | up to 60 minutes after tDCS onset | |
Secondary | Heat thermal threshold | Using the Quantitative sensory testing, this measure consists of the average temperature of 3 stimulus with increasing magnitude of heat where the participant presses a button to indicate when he/she first perceives heat. | percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session | |
Secondary | Heat pain tolerance | Using the Quantitative sensory testing, this measure consists of the temperature for a stimulus with increasing magnitude of heat where the participant presses a button to indicate the maximum heat tolerated. | percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session | |
Secondary | Moderate pain | Using the Quantitative sensory testing, this measure consists of the average temperature of 3 stimulus with increasing magnitude of heat where the participant presses a button to indicate pain perceived at a moderate level, i.e. level of 6 in a numeric pain scale (0 to 10). | percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session | |
Secondary | Unpleasantness sensation | This measure will be assessed using a numeric pain scale (0 to 10 in which 0 represents no unpleasant sensation and 10 extremely unpleasant sensation) with which participant will indicate how unpleasant was the temperature of the quantitative sensory testing stimulus for the heat pain threshold. | percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session | |
Secondary | Alpha wave power | Assessment of alpha wave power (8Hz to 12Hz) will be done using an 8 channel EEG device during an "eyes-open and eyes-closed" paradigm where participant is in a resting state at baseline and after each cross-over session. | up to 60 minutes after tDCS onset | |
Secondary | Beta wave power | Assessment of beta wave power (12Hz to 25Hz) will be done using an 8 channel EEG device during an "eyes-open and eyes-closed" paradigm where participant is in a resting state at baseline and after each cross-over session. | up to 60 minutes after tDCS onset | |
Secondary | Theta wave power | Assessment of theta wave power (4Hz to 8Hz) will be done using an 8 channel EEG device during an "eyes-open and eyes-closed" paradigm where participant is in a resting state at baseline and after each cross-over session. | up to 60 minutes after tDCS onset | |
Secondary | serum BDNF levels | Neuroplasticity biomarker will be assessed using serum brain-derived neurotrophic factor (BDNF) at baseline to be correlated with tdcs effects on primary outcomes | up to 60 minutes before tDCS onset |
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