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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The study investigates analgesic effects of expectations and deep brain stimulation on chronic and evoked pain in patients with Parkinson's disease.
The study includes patients with Parkinson's disease that are exposed to pain stimuli through injection of hypertonic saline. During pain induction and chronic pain evaluation deep brain stimulation treatment is regulated. Pain stimuli and regulation of deep brain stimulation are accompanied by verbal suggestions as to the analgesic effect of deep brain stimulation or no suggestions. During the test session patients evaluate their chronic and evoked pain and expectations.
The study procedure is repeated on two separate test days to investigate pain during deep brain stimulation treatment with or without verbal suggestions. All participants will complete all study conditions with no suggestions and verbal suggestions, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verbal suggestion | Other |
| |
| No suggestion | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suggestions | Behavioral | Verbal suggestions or no suggestions about treatment outcome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical rating scale (NRS) (Change) | A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective chronic and evoked pain in all study conditions. | Participants will be tested on two days. The numerical rating scale will be applied to assess chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day. |
| Numerical rating scale (NRS) (Change) | A numerical rating scale from 0 (no pain) to 10 (worst pain) will be used to assess participants' subjective expectations to chronic and evoked pain in all study conditions. | Participants will be tested on two days. The numerical rating scale will be applied to assess expectations to chronic and evoked pain at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day. |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) (Change) | Motor symptoms related to Parkinson's disease are assessed using the Unified Parkinson's Disease Rating Scale, part III in all study conditions. | Participants will be tested on two days. The Unified Parkinson's Disease Rating Scale will be used to evaluate motor symptoms at baseline and in the five study conditions (after each deep brain stimulation regulation) on each day. |
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Inclusion criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology and Behavioural Sciences, Aarhus University | Aarhus | 8000 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 28, 2023 | |
| Reset | Jul 24, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2023 | Jul 24, 2023 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013404 | Suggestion |
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Deep brain stimulation | Device | Regulation of deep brain stimulation intensity |
|
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004599 | Electric Stimulation Therapy |
| D013514 | Surgical Procedures, Operative |